Biotech Stocks Facing FDA Decision In September

(RTTNews) - As we head into another month of new drug approvals, it's time to take a look at some of the FDA-related news that grabbed headlines in August.

Celgene (CELG) and Agios Pharmaceuticals Inc.'s (AGIO) Idhifa, a new targeted treatment for relapsed or refractory acute myeloid leukemia, specifically for patients with an IDH2 mutation, was greenlighted by the FDA on August 1, 2017. About 8-19% of AML patients carry IDH2 mutation.

Johnson & Johnson (JNJ) received FDA approval for expanded use of Imbruvica for the treatment of adult patients with chronic graft versus host disease (cGVHD) on August 2, 2017. This is the first FDA-approved therapy for the treatment of cGVHD.

Jazz Pharmaceuticals' (JAZZ) Vyxeos got a stamp of approval from the FDA on August 3, 2017 for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed t-AML or AML-MRC.

A pan-genotypic hepatitis C drug Mavyret from AbbVie Inc.'s (ABBV) labs was approved by FDA on August 3, 2017. Mavyret is the first approved HCV treatment of eight weeks duration regardless of genotype while the standard treatment length is 12 weeks or longer.

Pfizer Inc.'s (PFE) Besponsa, a kind of targeted therapy called an antibody-drug conjugate, was approved in the U.S. on August 17, 2017 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The first drug for Parkinson's dyskinesia, Gocovri, developed by Adamas Pharmaceuticals Inc. (ADMS) was greenlighted by the FDA on August 24, 2017. The drug is expected to be available in the fourth quarter, and formally launched in January 2018.

Also of note is the U.S. President signing into law the FDA Reauthorization Act (FDARA) of 2017. The FDARA reauthorizes the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through fiscal year 2022.

Now that we have taken a look at the new drug approvals of August 2017, let's check out the FDA decisions coming up in September.