FDA Ends 2020 With More New Drug Approvals Than in 2019

Despite the serious challenges the FDA faced in responding to the COVID-19 pandemic in 2020, the agency ended the year approving more novel drugs than in four of the five previous years.

The agency gave the green light for 53 novel drugs, an increase of five from 2019, which saw 48 approvals. These approvals came despite significant obstacles in conducting inspections of drug facilities, which the agency overcame using alternatives such as record reviews in lieu of inspections and collaborations with regulatory partners abroad.

While 2020 saw fewer novel approvals than the 59 granted in 2018, last year’s tally topped 2017, 2016 and 2015, which saw 46, 22 and 45 approvals, respectively.

Noteworthy novel drugs approved by the FDA last year included:

• Kyowa Kirin’s Nourianz (istradefylline), the first adenosine A2A receptor antagonist for “off” episodes in Parkinson’s patients;
• Immunomedics’ Trodelvy (sacituzumab govitecan-hziy), the first antibody-drug conjugate (ADC) for adult metastatic triple-negative breast cancer patients;
• Ridgeback Therapeutics’ monoclonal antibody Ebanga (ansuvimab-zykl), the first FDA approved Ebola treatment in freeze-dried form;
• Aimmune’s Palforzia (peanut allergen powder), the first drug for treating peanut allergy in children;
• Genentech’s Evrysdi (risdiplam), the first oral drug for treating spinal muscular atrophy; and
• Nurtec ODT (rimegepant), the first calcitonin gene-related peptide (CGRP) receptor antagonist in orally disintegrating tablet form for acute treatment of migraine.

In 2020, the agency issued 613 warning letters in total, including ones given to device, food and tobacco companies compared to a total of 480 in 2019. The big jump most likely was due to a slew of warning letters sent to companies that were involved in COVID-19 scams and other fraudulent marketing activities.

Last year also saw its share of complete response letters (CRLs) issued because of the pandemic. The agency sent a CRL to scPharmaceuticals last month in part due to travel restrictions that prevented the agency from conducting pre-approval inspections at third-party manufacturing sites. The CRL delayed potential approval of the company’s Furoscix, an investigational drug for treatment of congestion in patients with worsening heart failure.

Similarly, Novartis’ Leqvio (inclisiran), a potential hyperlipidemia treatment for adults with elevated cholesterol, saw its review pushed back “due to unresolved facility inspection-related conditions.” The agency noted it did not conduct an on-site inspection of the third-party facility, which is manufacturing the drug, and said it would schedule an inspection when it’s safe to do so (DID, Dec. 21, 2020).

It isn’t known how many CRLs are issued from year to year because the FDA does not publicly release them, leaving it up to companies to disclose them. And it’s unclear when FDA inspections may begin returning to normal, but it is hoped that the availability of multiple COVID-19 vaccines in the first half of the year will allow for eased restrictions as the year progresses. — James Miessler