Following the FDA giving the green light to seven new medicines in December, it brought the approval total of new molecular entities (NMEs) in 2020 to 53, an amount that equals the number of new medicines that were approved in 1996 and ranking it second equal all-time just behind the 59 NMEs that were approved in 2018.
Recovering from a complete response letter (CRL) in 2018, Trevena Inc. resubmitted its NDA for oliceridine, branded Olinvyk. On Aug. 7, the drug received agency approval for managing moderate to severe acute pain in adults when the pain is severe enough to require an I.V. opioid and for patients whose alternative treatments are inadequate. The FDA has now approved a total of 34 new molecular entities (NMEs) so far this year. That total is well ahead of the 18 NMEs that were approved at this time in 2019 even though the FDA suggested back in May that it might have trouble meeting PDUFA dates due to the resources it needed to devote to the COVID-19 pandemic.
While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations.
After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks third behind the record 59 new medicines the agency approved last year and 53 in 1996.
The recent FDA approval of Ibsrela (tenapanor), Ardelyx Inc.’s treatment for irritable bowel syndrome with constipation in adults, brings, according to the agency’s data, the number of new molecular entities (NMEs) to 27 this year. With just three months remaining, it appears that the biopharma sector is on pace with the five-year average of about 43 NMEs approved annually.
