Biotech Stocks Facing FDA Decision In October 2019

(RTTNews) - It has been an eventful September, with a number of notable firsts achieved on the regulatory front.

On September 6, the FDA approved Ofev, the first treatment for patients with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD, a rare type of lung disease. Developed by Boehringer Ingelheim Pharmaceuticals, this drug was originally approved in 2014 for adult patients with idiopathic pulmonary fibrosis (IPF), which is another interstitial lung condition.

Novo Nordisk's (NVO) Rybelsus, a glucagon-like peptide (GLP-1) receptor protein treatment, secured FDA approval on September 20. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes.

The FDA greenlighted Jynneos for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk for these infections on September 24. Developed by Denmark-based Bavarian Nordic, Jynneos is the only currently FDA-approved vaccine for the prevention of monkeypox disease.

In what could be the first involving international regulators, the FDA and drug approval authorities in Canada and Australia, on September 17, simultaneously approved Eisai's Lenvima in combination with Merck's Keytruda for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

As of this writing, twenty-seven novel drugs have been approved so far this compared to 41 during the same period last year. 2018 holds the record for the maximum number of new drug approvals - with 59 drugs compared to 46 in 2017.

Now, let's take a look at the companies that await a ruling from the FDA in October 2019.