On the heels of unprompted EMA review of Covid drug, FDA schedules adcomm for potential EUA
The FDA is now following through on an emergency use filing for a repurposed cancer drug that European regulators initially took an interest in.
The US agency said Wednesday that it is convening an adcomm meeting of its Pulmonary-Allergy Drugs Advisory Committee, slated for Oct. 6. The company behind the adcomm is Veru, a Miami-based biotech that originally started out as a cancer company.
The federal agency said in a public notice that as part of the adcomm, one of the focuses of the experts during discussions will include “the treatment effect size in the context of the high placebo mortality rate, the limited size of the safety database, and identifying the proposed population.”
Veru filed an EUA request to the FDA earlier this year for its candidate sabizabulin to treat moderate to severe Covid-19 infection in patients that are at high risk for “acute respiratory distress syndrome.”
At the time, the biotech said in a pre-EUA meeting with the FDA that the regulatory agency agreed that it has enough data to support both an EUA and NDA submission for the drug candidate.
As for the EMA, Veru’s candidate was shown in a clinical study published in NEJM in July to reduce the relative risk of death from Covid-19 by 55%. Over the course of 60 days, just over 45% of those in the placebo group died, compared with just 20.2% of those who received the new drug.
Of the patients enrolled, all were hospitalized with Covid-19, 134 received the drug and 70 were given placebo. Veru said in April that the Phase III study for its Covid-19 treatment was shut down early by an independent data monitoring committee due to the drug’s “overwhelming efficacy.”
However, experts have said to exercise caution about over-interpreting the results. Part of the reasoning has been that over the last two years, there have been very few effective treatments for those hospitalized with Covid.
The Veru review from the EMA is the first to be triggered under Article 18 of the new EU regulation that expanded the agency’s role in the course of public health emergencies.
Shares of $VERU have fallen 22% after the market opened. However, the biotech is still up 122% over the last six months.