FDA Updates: COVID-19 Drug Approval, Priority Review for Tagrisso in New Indication


Gilead's Veklury gets full approval; AstraZeneca's Tagrisso heads toward second indication in NSCLC; another use for experimental antifungal therapy.

Gilead’s Veklury approved. FDA on Thursday approved the antiviral drug Veklury (remdesivir) to treat patients with coronavirus disease 2019 (COVID-19) when they need hospitalization. It is the first therapeutic to receive full FDA approval, which covers adults and children at least 12 years of age who weigh at least 88 pounds. The approval for Gilead Sciences does not cover some pediatric patients who had received the drug under the May 1, 2020, emergency use authorization (EUA); instead, the EUA was revised for younger patients as clinical trials in this population continue. FDA said the approval was based on data from three trials involving patients hospitalized with mild to severe COVID-19, including a 1,062-patient trial by the National Institute of Allergy and Infectious Diseases, which found patients taking the drug recovered five days earlier than those taking a placebo.

Priority review for new Tagrisso indication. AstraZeneca’s Tagrisso (osimertinib) has been granted priority review for its supplemental new drug application for the adjuvant treatment of patients with early-stage epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) following surgery for tumor removal. Although 30% of these patients are diagnosed in time for current treatment regimens to cure their disease, up to 50% see disease recurrence. FDA’s action follows results from the ADAURA trial presented in May at the American Society of Clinical Oncology, which found that Tagrisso improved disease-free survival 79% compared with placebo, and that the two-year, disease-free survival rate was 89%, compared with 53% for placebo. Priority review will shorten the review timeline to six months from the standard 10 months.

Second breakthrough therapy designation for olorofim. F2G has received its second breakthrough therapy designation for olorofim, which is in phase 2b development for the treatment of life-threatening fungal infections. This new breakthrough designation is for coccidioidomycosis, or valley fever. FDA has previously granted olorofim orphan drug designation coccidioidomycosis, an endemic fungal infection that occurs primarily in the desert Southwest of the United States but also in Mexico, Central America, and South America. Infection begins by inhalation and can spread to any part of the body, even in otherwise healthy individuals. When the infection reaches the brain, it produces a devastating illness that cannot always be controlled with any currently available agent.

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