Biotech Stocks Facing FDA Decision In February

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2018 was a banner year not just for novel drug approvals but for novel device approvals as well. Last year, 59 novel drugs and 106 novel devices were greenlighted by the regulatory agency compared to 46 novel drugs and 99 novel devices approved in 2017.

As we head into February, it's time to take a look back at some of the regulatory news that made headlines in January.

On January 16, the FDA approved the first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy. The generic version is developed by Teva Pharma. (TEVA).

On January 23, the FDA authorized Aptima Mycoplasma genitalium Assay, the first test to aid in the diagnosis of a sexually transmitted infection known as Mycoplasma genitalium. Developed by Hologic Inc., Aptima Mycoplasma genitalium Assay was reviewed through the De Novo premarket pathway, a regulatory pathway for low-to-moderate-risk devices of a new type.

The partial government shutdown, the longest shutdown in U.S. history, which began on December 22, 2018, ended temporarily on January 25, 2019. About 40% of the FDA's workforce was furloughed during the shutdown due to the lack of funding.

During the shutdown period, the FDA is not legally authorized to accept new fees or new medical product applications. So, this may mean a delay in approval of new drug and device applications. Aimmune Therapeutics Inc. (AIMT), which submitted its Biologics License Application for peanut allergy drug AR101 on December 21, 2018, was notified by the FDA that its application will be taken up for review only when the shutdown has ended.

Given the surge of cell and gene therapy products entering early development, the FDA has planned a series of clinical guidance documents aimed at helping advance the field of cell and gene therapy. By 2020, the FDA anticipates receiving more than 200 investigational new drug applications (INDs) per year, building upon a total of over 800 active cell-based or directly administered gene therapy INDs currently on its file. And by 2025, the FDA expects to be approving 10 to 20 cell and gene therapy products a year.

Now, let's take a look at the biotech stocks that await a ruling from the FDA in February 2019.

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