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FDA Decisions In November: The Month In Review

FDA Decisions In November: The Month In Review

Rounding out a month marked mostly by positive decisions, FDA announced its approval late for Sublocade, a once-monthly injectable buprenorphine product for the treatment of opioid addiction.

U.K.-listed Indivior PLC, the developer of the drug, surged on the London Stock Exchange Friday following the announcement. The drug is likely to be made available in the U.S. in the first quarter of 2018.

Innovation was at its best in November. NME — or new molecular entities — approvals were brisk, with five NMEs gaining approval, taking the tally for the year to 40. In comparison, there were only 22 approvals for the whole of 2016.

A NME is a drug that contains an active moiety that has never been approved by the FDA or marketed in the U.S.

NME Approvals for November

Nov. 2 – Valeant Pharmaceuticals Intl Inc (NYSE: VRX)'s Bausch & Lomb and NICOX SA (OTC: NICXF) announced FDA approval for Vyzulta, the first prostaglandin analog, for treating interocular pressure in patients with open-angle glaucoma or ocular hypertension.

Nov. 8 – Merck & Co., Inc. (NYSE: MRK)'s NME Prevymis for preventing cytomegalovirus infection in adult allogenic stem cell transplant patients was accorded FDA approval.

Nov. 14 - AstraZeneca plc (ADR) (NYSE: AZN)'s Fasenra, an add-on maintenance treatment for severe eosinophilic asthma, received FDA approval.

Nov. 15 - Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) received the FDA nod for its lead product candidate rhGUS, indicated to treat Sly syndrome.

Nov. 16 - Roche Holding Ltd. (ADR) (OTC: RHHBY)'s Genentech unit announced FDA approval for  hemlibra, used to prevent or reduce the frequency of bleeding episodes in hemophilia A patients who have developed antibodies called Factor VIII inhibitors.

See also: Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

Other Approvals

Nov. 7 - Collegium Pharmaceutical Inc (NASDAQ: COLL)'s sNDA, or supplemental new drug application, for enhancing the label for Xtampza ER —an

extended-release opioid for treating severe pain — was approved. 

Although the stock did not react much immediately after the approval was announced, it rallied subsequently and ended November with a 67-percent gain. 

Nov. 7 - Keryx Biopharmaceuticals (NASDAQ: KERX) announced FDA approval for its sNDA for Auryxia to treat iron deficiency anemia in patients with chronic kidney disease who are not on dialysis.

Counterintuitively, the stock pulled back after the FDA approval. It was down 26 percent in November. 

Nov. 9 – After two unsuccessful attempts, Dynavax Technologies Corporation (NASDAQ: DVAX) finally succeeded in getting the FDA on board for its Hepatitis B vaccine Heplisav-B in adults.

It was the classic case of "buy the rumor and sell the news" in the case of Dynavax, which rose to a high of $23.20 Nov. 6 only to pull back gradually amid and after the announcement. The stock ended November down about 9 percent.

Nov. 9 - Heron Therapeutics Inc (NASDAQ: HRTX) announced after the close the FDA approved its CINVANTI injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. The company said it plans a commercial launch in January. 

Heron shares added about 15 percent in November.

Nov. 10 – The FDA expanded the use of Bristol-Myers Squibb Co (NYSE: BMY)'s Sprycel tablets to treat children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase 1.

Related Link:

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Posted-In: IndiviorBiotech News Health Care FDA Trading Ideas General Best of Benzinga


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