FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic

 

The COVID-19 pandemic disrupted nearly all industries in 2020, with the pharmaceutical industry being no exception. For the pharmaceutical industry, the lack of face-to-face meetings caused the U.S. Food and Drug Administration (FDA) to implement regulatory workarounds to stay on top of drug and biologics approvals.

A news feature published in a recent issue of Nature Biotechnology suggests these workarounds, which were the driving force for a record number of drug approvals in 2020, are here to stay.

At the beginning of the COVID-19 pandemic, face-to-face industry meetings dwindled and were rapidly replaced by Webex and Microsoft Teams meetings. And despite the lack of in-person meetings designated for drug and biologic approval decisions, by December 31 the FDA had approved almost the same number of drugs and biologics during 2020 as it had in the prior year.

“COVID-19 confronted us with the need to better triage sponsors’ questions,” said Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, in an interview with Nature Biotechnology. “That was perhaps the single biggest takeaway from the pandemic related to product applications.”

Marks said the FDA noticed that with some COVID-19-related files the act of resolving just one issue was enormously helpful for the sponsor and accelerated the development lifecycle. Prior to the pandemic, a small company would have waited up to 75 days, a standard waiting period for a type C meeting, for even minor advice on one aspect of the manufacturing process, control group or appropriate of an animal model.

“It’s a long time to wait,” Marks said. “Going forward, we would like to find ways of increasing interactions so that sponsors’ issues don’t fester.”

During 2020, evidence showed that patient-centered development represented a desirable direction in drugs and biologics regulation. A watchword in drug approvals is “convenience,” and this certainly applies to patients in addition to the healthcare industry at large.

One move toward patient convenience was observed in August 2020, with the approval of a self-injection human growth hormone formulation from Novo Nordisk. The technical key to the therapy was borrowed by Novo from the development of the company’s long-acting insulin analog.

Another patient-centered therapy from Halozyme Therapeutics and Hoffmann-La Roche was approved during the pandemic, which allows patients to avoid treatment in the hospital. This represents a desirable target, especially during a pandemic where clinicians are trying to reduce patient and healthcare staff exposure to SARS-CoV-2. Another patient-centered drug from Roche, Evrysdi (risdiplam), was approved in August 2020 for spinal muscular atrophy. The therapy is formulated for infants as a strawberry-flavored beverage that can be administered at home.

Difei Yang, a senior biotech analyst at Mizuho Securities USA, noted in the Nature Biotechnology feature that the pandemic fostered a synergy between biotech firms and big pharma, a combined force that will likely persist over time.

“Biotech brings strengths in technology innovation and an approach to clinical validation that brings products forward in the most valuable indications or disease settings,” Yang said. “Pharma, on the other hand, has the wherewithal to navigate complex regulatory environments, invest in new manufacturing technologies, and work with payers