The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.
The process for vetting and authorizing important new therapies by the Center for Drug Evaluation and Research (CDER) remained strong and productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies. CDER’s final count was 53 new molecular entities approved for market [see Novel Drug Approvals for 2020 | FDA], plus another five new biologics from the Center for Biologics Evaluation and Research (CBER) [see 2020 Biological License Application Approvals | FDA]. And that doesn’t include important vaccines and drugs that received Emergency Use Authorizations (EUAs) from the agency to combat the pandemic.
The final tally for drugs falls short of the record number of 59 new drugs approved in 2018 but surpasses last year’s total of 48 new drugs. Approval numbers vary, as some analysts don’t count certain imaging agents or may add cellular therapies to the drugs list, and some new biologics are not considered therapies. Gilead Sciences, Roche, Eli Lilly, and Bristol Myers Squibb all won notable new drug approvals, while a number of small newcomers entered the market. Cancer therapies led the tally, with 18 new therapies to treat lung cancer, breast cancer, multiple myeloma, and other conditions. There were eight new therapies for rare conditions, and several for infectious diseases such as Ebola, malaria, Chagas disease, HIV and, certainly, COVID-19.
Analysts question whether the new drug approval rate will continue this year, with most inspections of manufacturing facilities and clinical sites still on hold and FDA issuing more complete response letters (CRLs) announcing delays in vetting new drugs for market. The continued rise in infections from COVID-19, moreover, will further strain agency resources as review staff is diverted to analyze submissions for new vaccines and therapies to counter the pandemic.
The agency also will experience important changes in leadership under the Biden administration, which often leads to policy changes and puts certain initiatives on hold. FDA recently announced that Janet Woodcock has become a principal medical adviser to Commissioner Stephen Hahn. Last year, Woodcock stepped away from her long-held role as CDER director to head up the program for vetting therapeutics under the administration’s Operation Warp Speed. Now she also will work with Anand Shah, FDA deputy commissioner for medical and scientific affairs, to expand FDA’s COVID-19 Pandemic Recovery Preparedness Plan (PREPP). CDER Deputy Director Patrizia Cavazzoni continues to serve as the Center’s acting director, while Woodcock remains recused from participating in regulatory decisions related to new therapeutics.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.