Even before year-end, 2020's new drug approvals match FDA's 2019 stats

Regulatory NewsRegulatory News | 07 December 2020 |  By 

The US Food and Drug Administration (FDA) has kept its new drug approvals for 2020 on track to match or best approvals in 2019, despite the COVID-19 pandemic.
By 4 December 2020, FDA had amassed a list of 48 new molecular entities and new therapeutic biological products approved by the agency’s Center for Drug Evaluation and Research (CDER), equaling the total for 2019. (RELATED: FDA: 2019 continues uptick in orphan drug approvals, Regulatory Focus 06 January 2020)
As the pandemic blossomed and in-person inspections became difficult or impossible to complete, FDA has issued guidance for industry in the form of a question-and-answer document addressing manufacturing, supply chain, and drug and biological product inspections during the public health emergency.
In terms of pre-approval inspections, FDA has been using “other tools and approaches where possible,” including relying on foreign regulators and seeking detailed records and information from applicants and other inspected entities.
While FDA has expressed a commitment to continuing “mission-critical” inspections, the agency still reserves the right to take into consideration the safety of its investigators and other participants in the inspection process. Pandemic-related travel restriction have hampered inspections and, in some cases, have caused the agency to miss its Prescription Drug User Fee Act (PDUFA) action dates.
Bristol Myers Squibb’s PDUFA action date was 16 November 2020 for its biologics license application (BLA) for the lymphoma treatment lisocabtagene maraleucel (liso-cel). However, the company announced on that date that “The FDA was unable to conduct an inspection…due to the travel restrictions related to the COVID-19 pandemic.”
In the case of liso-cel, FDA is deferring action until a physical inspection can occur; no new action date has been set, according to the pharmaceutical company.
However, Liquidia Technologies received a complete response letter (CRL) from FDA on 25 November for its novel inhalation powder, LIQ861 (Treprostinil) to treat pulmonary arterial hypertension. According to the firm’s press release announcing the CRL, FDA “reconfirmed the need to conduct on-site pre-approval inspections (PAIs) of two of Liquidia’s U.S. manufacturing facilities before the application can be approved.”
Although the press release said that FDA also needed more clarification about Liquidia’s chemistry, manufacturing and controls data, the firm said that inability to conduct in-person inspections also factored into the agency’s decision:  “The FDA noted it had been unable to conduct these inspections during the initial review cycle due to COVID-19 related travel restrictions.”
In 2020, 15 of the 48 approvals were for cancer therapies; FDA also gave the nod to four new radiotracers including Tauvid (flortaucipir F18, Avid Radiopharmaceuticals), indicated for use as a diagnostic agent for patients with Alzheimer’s disease.
Remdesivir’s October 2020 approval (Veklury, Gilead) made it the first drug to receive full FDA approval for the treatment of COVID-19. The action came soon after FDA also approved the first treatment for Ebola virus.
A number of applications still sit before FDA with PDUFA action dates between now and the end of 2020; whether


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Tags: coronavirus, FDA, US

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