FDA Approves New Drug for COVID-19 Prevention

The US Food and Drug Administration has granted an emergency use authorization for a new COVID-19 prevention drug in patients who are unlikely to mount an adequate immune response to vaccines.

Developed by Invivyd, Inc., a Massachusetts-based pharmaceutical company, Pemgarda (pemivibart) is approved for use in adults and adolescents aged 12 and older and weighing at least 88 lbs (40 kg).

The drug, formerly known as VYD222, is intended for use in individuals with moderate to severe immune compromise due to certain medical conditions or immunosuppressive treatments, making them unlikely to generate an adequate immune response to COVID-19 vaccination. This includes patients with blood cancers and solid organ transplant recipients.

Pemgarda is the first pre-exposure prophylaxis monoclonal antibody (mAb) to receive emergency use authorization (EUA) from the FDA based on a novel, rapid, repeatable immunobridging trial design

“We are proud that roughly one year after initiating the Phase 1 trial of our mAb, now known as Pemgarda, we are expecting to have product available for order imminently, with initial supply already packaged and awaiting final release at our US-based third-party logistics provider,” said Dave Hering, Chief Executive Officer of Invivyd.

As a monoclonal antibody treatment, Pemgarda serves as a substitute antibody that helps the immune system fight SARS-CoV-2, the virus that causes COVID-19.

In recent years, the FDA pulled the EUAs for monoclonal antibody treatments like EVUSHELD and bebtelovimab because they no longer protected against new COVID-19 strains.

Pemgarda does not replace vaccination

Pemgarda should not replace the COVID-19 vaccine in individuals who can be vaccinated. Wait at least two weeks after vaccination to receive Pemgarda.

The drug is not authorized to treat COVID-19 or to prevent the disease after being around someone infected with SARS-CoV-2.

Pemgarda is not approved for use in patients currently infected with SARS-CoV-2 or who have a known recent exposure to an infected individual.

Pemgrada is given to patients through an intravenous infusion, and it takes about 60 minutes to finish. The drug is administered in a healthcare setting where a patient will be observed for at least two hours after the infusion is finished.

The most common Pemgarda side effects are allergic and infusion-related reactions, common cold, viral infection, flu-like illness, tiredness, headache, and nausea.

The FDA warns that the drug may have serious and unexpected side effects, as it is still being studied, and all of the risks may be unknown at this time.

In the trial four out of 623 participants in the trial experienced anaphylaxis, a severe, life-threatening allergic reaction. Pemgarda recipients who develop allergy symptoms, such as rash or trouble breathing, should seek medical help right away.

About 3% of American adults are immunocompromised and less capable of fighting SARS-CoV-2 infection. For them, Pemgarda shows promise in offering better protection against COVID-19.


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