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Biotech Stocks Facing FDA Decision In June 2019

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As another month comes to a close, it's time to take a look back at some of the pharma news stories of May, and look ahead at what's coming next over the horizon on the regulatory front.

Here are some of the "firsts" related to FDA approval that happened in May...

The first vaccine for the prevention of dengue disease in endemic regions was approved on May 1, 2019. The vaccine, Dengvaxia, developed by Sanofi Pasteur, is indicated for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

The first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder, received the regulatory nod on May 6, 2019. The drug known as Ruzurgi is developed by privately-held Jacobus Pharmaceutical. There is already an approved drug for the treatment of adults with Lambert-Eaton myasthenic syndrome, which goes by the name Firdapse. Developed by Catalyst Pharmaceuticals, Firdapse was approved last November, and it carries a price tag of $375,000 a year.

The first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots was approved by the FDA on May 16, 2019. The drug, which goes by the name Fragmin injection, is used to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. Fragmin was initially approved by the FDA in 1994 for adults.

On May 23, 2019, the U.S. regulatory agency cleared the first diagnostic tests for extragenital testing for Chlamydia and Gonorrhea. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum.

So far this year, i.e, January to May, only 10 novel drugs have been approved compared to 15 during the same period last year.

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

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