Btobioinnovation.com 

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com 

SPECIAL REPORT #22.2

U.S. FDA approves 63 new treatments in 2021

In 2021, the U.S. FDA has approved 50 new treatment options through the Center for Drug Evaluation and Research (CDER) and 13 new Biological License Application (BLA) approvals through the Center for Biologics Evaluation and Research (CBER) – vaccines/blood/biologics.  These numbers include two imaging agents.

Some of these products are innovative new products that have never been used in clinical practice. Others are the same as previously approved products that will compete with those products on the market. Certain drugs are classified as new molecular entities (NMEs) for purpose of review. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the agency.

Two approvals made the international headlines: the controversial approval for Biogen’s Alzheimer’s disease drug Aduhelm on July 7 and BioNtech and Pfizer’s COVID-19 vaccine Comirnaty on August 23.

Four companies: Argnex – with Vyvgart to treat generalised myasthenia gravis -, Apellis Pharmaceuticals – with Empaveli to treat paroxysmal nocturnal haemoglobinuria -, BridgeBio Pharma – with Nulibry to reduce the risk of mortality in molybdenum cofactor defiency Type A, a rare disease – and ChemoCentryx – with Tavneos to treat severe active anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis,  received their first-ever U.S. FDA approval.

According to our own analysis we find that:

CDER has approved:

• 35 new treatments based on chemically designed or chemically modified molecules (possibly 29 “NCEs”)
• 9 antibodies and antibody conjugates and one nanobody.
• 5 recombinant proteins
• 1 small interfering RNA (siRNA)

CBER has approved

• 5 vaccines including Comirnaty from BioNtech and Pfizer, but not the ones from Moderna and Johnson & Johnson which both still only received Emergency Use Authorisation (EUA) and not the full approval.

In a November report, the U.S. FDA indicated that the agency struggled to keep up with inspection duties due to the COVID-19 pandemic and that 55 new drug applications were facing inspection delays.

 Paris, January 6, 2022

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