Dr. Samirul Islam

08/15/2021

Systemic lupus erythematosus, referred to as SLE or lupus, is a chronic (long-term) disease that causes systemic inflammation which can affect multiple organs.

When healthy, our immune system protects the body from germs and cancers. With lupus, the immune system misfires and attacks “self”, the patient’s own tissues, in a process called autoimmunity

The cause of lupus is not well understood; there is likely to be a genetic component but environmental factors are thought to play a role as well. Hormonal factors are also implicated.

The disease most commonly develops in adult females between the ages of 15 and 40.

People with lupus often have disease "flares," in which symptoms worsen, followed by periods of remission, in which symptoms improve.

The frequency of these flares varies from person to person.

Symptoms are mild in some people and life-threatening in others. However, treatments are available to relieve symptoms, reduce inflammation and minimize organ damage.

SLE is associated with complex, chronic and challenging life experiences, which can have a profound negative impact on a patients’ quality of life

08/14/2021

The Food and Drug Administration has approved an additional booster vaccination dose for those with weak immune systems or who have received organ transplants, it announced on Thursday.

08/10/2021

Skinny labelling of generics: the beginning of the end for this

1. The Drug Price Competition Act allows generic drug companies to seek FDA approval for a generic
product before patents for the relevant brand-name drug have expired.
2. Then, the generic is approved by the FDA for other non-patented indications without the need to
sacrifice safety and efficacy.
3. At first, they avoid the patented indication approval to market a brand-name drug is prescribed.

Coreg (carvedilol)
-Hypertension;
-Congestive heart failure (CHF); and
-Left ventricular dysfunction following
-Myocardial infarction (LVD-MI).

Generic carvedilol
-Hypertension, and
-LVD-MI (at least partially overlaps with the CHF indication), and Teva infringed a GSK patent by urging doctors to prescribe its generic version of Coreg for congestive heart failure.

For example:
Vascepa vs. Icosapent ethyl capsules
-Icosapent ethyl capsules manufactured by Hikma, and Dr. Reddy’s generic drugs for Vascepa have been
approved only for severe hypertriglyceridemia but not for the cardiovascular indication.
-When they launch, they will do so with skinny labels that do not include the cardiovascular indication
and later curves to the CV indication.

In a controversial decision that could have far-reaching impact on the generic drug industry's practice of "skinny labeling," a U.S. Federal Circuit Appeals panel has reaffirmed a $235 million judgement against Teva, ruling for GlaxoSmithKline.

08/08/2021

Because of an increasing number and complexity of treatment options for lipid‐lowering therapy in patients with atherosclerotic cardiovascular disease, guidelines recommend greater active involvement of patients in shared decision‐making. However, patients' understanding and perceptions of the benefits, risks, and treatment objectives of lipid‐lowering therapy are unknown.

Background Because of an increasing number and complexity of treatment options for lipid‐lowering therapy in patients with atherosclerotic cardiovascular disease, guidelines recommend greater activ...

08/07/2021

US Daily Cases, Hospitalizations, Deaths From Delta Variant Up 40% Week-Over-Week

The Washington Post (8/5, Suliman, Johnson, Pager, Pietsch, Knowles) reported new daily cases, hospitalizations, and deaths from the Delta variant “are all surging as millions of Americans remain unvaccinated, federal health officials warned Thursday.” Daily cases have surpassed 100,000 for the first time since February 2021, and the seven-day average of hospital admissions are “up by more than 40 percent from the week before and deaths trending up by roughly the same rate.” On Thursday in response, the Biden Administration “announced a new push to vaccinate young people as they head back to school, backing initiatives such as hosting pop-up clinics on campus; sending pediatricians to back-to-school nights to discuss the shots with parents; and incorporating vaccination against covid-19 into physicals for student athletes.” Further, Secretary of Education Miguel Cardona announced that the Administration is partnering with groups such as the American Academy of Pediatrics and the National Parent Teacher Association to help get children 12 and older vaccinated.

WHO Calls For Moratorium On COVID-19 Vaccine Boosters
The New York Times (8/4, Kwai, Mueller, Slotnik, Hassan) reported WHO Director-General Tedros Adhanom Ghebreyesus on Wednesday “urged wealthy nations not to distribute [COVID-19] booster shots until at least the end of September to reserve supplies and help every country inoculate at least 10 percent of its population.” Officials with the agency “went to pains to distinguish between booster shots used to shore up immunity in vaccinated populations, for which the science is not yet clear, and additional doses that may be needed by the immunocompromised to develop immunity in the first place.”
On its website, CNBC (8/4, Mendez) reported the WHO “said the moratorium should last at least two months, to give the world a chance to meet the director-general’s goal of vaccinating 10% of the population of every country by the end of September.”

The Washington Post (8/4, Rauhala, Knowles, Sun, McGinley) reported, “The World Health Organization is calling for a moratorium on booster shots of coronavirus vaccines through at least September as poorer countries struggle to access the shots, even for high-risk populations such as health-care workers and the elderly.” The Post added, “Some wealthy countries such as Germany, Israel and Russia have already made the controversial move to prioritize booster shots – often focusing on fully vaccinated but higher-risk people – instead of donating the doses to nations in greater need.”
US Hits Major Milestone With 90% Of People Over 65 Vaccinated Against COVID-19
Kaiser Health News (8/4, Galewitz) reported the US on Tuesday “hit a milestone that some thought was unattainable: 90% of people 65 and older are at least partly vaccinated” against COVID-19. Overall, about 70% of adults across the US have been at least partly vaccinated, along with 68% of children over 12. AARP Vice President Bill Walsh called the milestone “a real success story in vaccine distribution” but there remains more to do. He said, “We want everyone to get vaccinated.”

Delta Coronavirus Variant Accounts For No Less Than 93% Of US COVID-19 Cases, CDC Estimates
The Hill (8/4, Weixel) reported the Delta “variant accounts for at least 93 percent of all sequenced coronavirus [cases] in the U.S., according to estimates from the” CDC. For the two weeks that ended “July 31, all the different lineages of the delta variant made up about 93 percent of cases that were sequenced.” In some regions “of the country with low vaccination rates, especially the Midwest, the percentages are even higher.”
The New York Daily News (8/4, Matthews) reported “areas in the Midwest, including Iowa, Kansas, Missouri, Nebraska, Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming, had even higher percentages, with some places reaching 98%.” CDC Director Rochelle Walensky said, “The emergence of the Delta variant has led to a rapid acceleration of community transmission in the United States, putting more Americans at increased risk, especially if they are unvaccinated.”
US News & World Report (8/4, Lardieri) said “the main delta strain accounted for 83.4% of cases in the last two weeks of July, an increase from 72% in the two weeks prior.”

08/03/2021

On July 28, 2021, the U.S. Food and Drug Administration (FDA) approved Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn) injection as the first interchangeable biosimilar product in the United States.

• With this new approval, Semglee is both biosimilar to and interchangeable with (can be substituted by the pharmacist, depending on state laws) with its long-acting insulin reference product, Sanofi’s Lantus and Lantus SoloStar (insulin glargine).

• Semglee is not interchangeable with other marketed insulin glargine products, Lilly’s Basaglar and Sanofi’s Toujeo.

• With Semglee’s “interchangeable” designation, state-regulated pharmacist interchangeability laws can be enacted by pharmacists to substitute between Lantus and Semglee.

• Despite the interchangeability status between Lantus and Semglee, payer formularies will continue to impact access and out-of-pocket costs. Pharmacists interchanging (or substituting) one product for the other may inadvertently increase a patient’s out-of-pocket costs by doing so, depending on the preferred formulary product.

• To complete this interchangeable approval, Viatris/Biocon will be launching a new product label with new National Drug Codes (NDCs). Viatris/Biocon indicated the transition from the current Semglee product to the interchangeable package presentation will occur over the next few months and will be completed by the end of 2021. Viatris/Biocon will supply an initial marketing date for the new NDCs, which will start the “first interchangeable biological product” exclusivity that will likely block the FDA from approving another Lantus interchangeable product for 1 year. Until Viatris re-launches Semglee with the new interchangeable label, the current Semglee presentation on the market is technically not interchangeable.

08/03/2021

I have been waiting for this since Donald Trump received this effective treatment for COVID. Our nurses have been administering monoclonal antibodies for more than 7 months to people in their homes. The results are fantastic. No one went to ER, no one was hospitalized, and no one died after receiving this treatment as advised. Moreover, we see more and more people who were vaccinated with Moderna or phyzer in the beginning of the year as well as most recently in April and May with breakthrough COVID moderate symptoms. Tge viral load of vaccinated and unvaccinated persons infected with SARS-CoV-2 seems the same.

We have not seen breakthrough cases in people who received monoclonal antibodies. Have you?

Everybody should be able to receive Regeneron, as a treatment and prevention.

Dear healthcare providers, please stop telling people “just isolate yourself , drink fluids, and take vitamines, and call 911 when your spo2 drops below 90%” Enough is enough. Every person who starts exhibiting symptoms should be treated aggressively on day 1 and have access to monoclonal antibodies! It can be done SQ or IV and majority of adults and children age 12 weighting at least 40 kg are eligible !

“Limitations of Authorized Use
REGEN-COV (casirivimab and imdevimab) is not authorized for use in patients: who are hospitalized due to COVID-19, OR
who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.”
https://lnkd.in/gkExJQQ

Doctors, use your autonomy! Regeneron prescription is at your discretion! Save lives. Everyone is “at high risk for developing severe COVID-19 symptoms or the need for hospitalization”. Regeneron (REGEN-COV (casirivimab and imdevimab)) is now authorized for post-exposure prophylaxis for prevention of COVID-19 for at high risk patients

https://www.fda.gov/media/145610/download?utm_medium=email&utm_source=govdelivery

08/01/2021

WEIGHT LOSE DRUGS AND THE PIPELINEs EXPLAINED

Wegovy (semaglutide)

-People with Wegovy (semaglutide) group lost an average of 17% of their initial body weight.
-Wegovy is a game-changer because we have achieved about 4.9% to 10% weight loss with the current weight-loss medications.
-An anticipated list price of around $1,300, expensive among all other drugs in the pipeline
-Not covered by Medicaid/Medicare/affordable care Acts for weight loss indications and PA required for diabetes.
-Semaglutide approved for use in adults at least 18 years old
-It takes a few months to reach the target dose, and the side effects are nausea, vomiting, and diarrhea.

Qsymia (phentermine/topiramate)
-An average weight loss ranging from 5% (at lower doses) to around 10% (at higher doses)
-Inexpensive oral weight loss medication
-People can develop an addiction

Contrave (bupropion/naltrexone)
-People can lose an average of 9.3% of their baseline body weight

Liraglutide (Saxenda)
-An average weight loss of 8% from baseline body weight.
-Saxenda was recently approved for use in children at least 12 years old.

Tirzepatide
-In phase 3 clinical trials
-Tirzepatide shows significantly better long-term blood sugar control (called A1C) and weight loss than semaglutide.
-Results from the clinical trial reveal that tirzepatide lowered blood sugar and body weight in people with type 2 diabetes significantly more than Ozempic.

08/01/2021

Its been incredible few months preparing for this launch, especially in this virtual environment!! 🚀🚀🚀

Fourth indication for mepolizumab in the US for eosinophil-driven diseases.

07/31/2021

I just started remdesivir on a 25 year old unvaccinated girl. It’s been a couple months that we haven’t needed to use this medication in our hospital, but today I’ve already started 2 new patients on it within my 1st hour on the clock. Per guidelines, the patients both required supplemental O2 - a prerequisite for considering this expensive treatment. The cost of remdesivir is around $4K per patient and is completely absorbed by the hospital as insurance does not reimburse for this medication since it does not have any proven mortality benefit - I include this for the conspiracy theorists that will surely have opinions.
Bottom line: COVID has not gone away. The Delta variant is here and more variants will keep arising until we decide to slow down transmission by getting vaccinated and contributing to herd immunity.
Why it’s important: the faster a virus transmits, the faster it mutates. The less viable hosts a virus can replicate in, the slower it will mutate. At the current rate of spread, one of these mutations can and will escape the immunity provided by our vaccines at which point we would have to start this process all over again (think 2020).
The point: no matter your personal current Covid risk level, get vaccinated. Do it for the greater good if not for yourself and your family. Do it so that you’re contributing to ending this pandemic instead of unwittingly contributing to the death of someone’s loved one.

07/30/2021

Major step forward for biosimilars in the US! Hopefully we see more biosimilars achieving this status which will remove one barrier to patient access. Now we watch how payers and PBMs treat this product and does it move in the "generic" direction

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic...

07/30/2021

The drug Aduhelm and its controversy against FDA approval.
In 2015, Biogen announced positive results from the first clinical trial of Aduhelm, showing that the drug can remove beta-amyloid from the brains of patients.
As results were examined under greater scrutiny, they seemed less promising. Even with the doubts, Biogen started two large Phase 3 clinical trials. The studies were considered risky from experts and the stock price of the company fell. Other competitors: Pfizer, Roche and Eli Lilly had also run trials of their own beta-amyloid targeting antibodies but failed to prove that the drug helped slow the decline of Alzheimer’s patients. Between 2015-2018: nearly 3300 patients with Alzheimer’s were enrolled in two identical Phase 3 clinical trials: Emerge and Engage 2/3 were randomized to receive monthly infusions containing either a low or high dose of Aduhelm and remaining patients were given placebo infusions. Main goal was to show that Aduhelm could slow the loss of cognition more than placebo, assessed 18 months after treatment. Towards the end of 2018 and early 2019: Biogen came under increasing pressure for plans for an interim analysis which they were hesitant to complete due to belief that independent monitors would prematurely conclude Aduhelm wasn’t effective enough to justify continuing the studies....