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7 PDUFA Dates to Mark on Your Calendars for September

9/6/2017 5:55:49 AM

7 PDUFA Dates to Mark on Your Calendars for September September 6, 2017
By Mark Terry, Breaking News Staff

The U.S. stock market had a rough day after Labor Day. Analysts have blamed concerns over North Korea, the damage caused by Hurricane Harvey in Texas, and Hurricane Irma that looks likely to hammer Florida. The iShares NASDAQ Biotechnology Index (ETF) for September showed a loss of 0.69 percent, and the NYSE ARCA Biotech Index showed a 1.72 percent increase.

But it’s not all gloom and doom. There are at least seven companies with drugs facing hopeful approvals this month by the U.S. Food and Drug Administration (FDA). Let’s take a look.

1. Mylan and Biocon

Mylan (MYL) and Biocon had a PDUFA date of September 3 for their biosimilar to Roche (RHHBY)’s breast cancer drug Herceptin (trastuzumab). Roche’s patent on Herceptin will expire in the U.S. by 2019, which is opening the gate to a flood of generic biosimilars. In 2015, Herceptin brought in $6.79 billion, although analysts project sales of $3.98 billion by 2022. As of this writing, there is no news on its approval.

2. Allergan and Amgen

Allergan (AGN) and Amgen (AMGN) also have a biosimilar candidate, ABP 215, this one for Genentech (RHHBY)’s Avastin (bevacizumab) for several cancers, including unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC). It is also used to treat metastatic carcinoma of the colon or rectum, metastatic renal cell carcinoma, and other cancers. The companies are expecting approval by Sept. 14.

3. Neos Therapeutics

With a PDUFA date of Sept. 15, Neos Therapeutics (NEOS) is awaiting word on its drug, NT-0201 for attention deficit hyperactivity disorder (ADHD). The drug is an amphetamine XR liquid suspension. The company indicates that the drug, which is a formulation of methylphenidate, best known as the brand names Ritalin and Adderall, is a formulation designed to be taken orally in an easily dissolvable pill. The typical dosage is a large pill, which younger children—and plenty of older children—have difficulty swallowing. The company’s extended-release formula is designed to disintegrate on the tongue.

4. GlaxoSmithKline and Innoviva

GlaxoSmithKline (GSK) and Innoviva (THRX) are waiting on its New Drug Application (NDA) for a closed triple combination therapy of fluticasone furoate/umeclidinium/vilanterol for chronic obstructive pulmonary disease (COPD). The company filed for the therapy in November 2016 and has a PDUFA date of Sept. 21.
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5. Johnson & Johnson

On August 2, the FDA’s Arthritis Advisory Committee did not recommend approval of Johnson & Johnson (JNJ)'s Plivensia (sirukumab) to treat moderate to severe rheumatoid arthritis. The committee voted unanimously in support of the efficacy data, but had concerns over the drug’s safety profile. The PDUFA date is Sept. 23.

6. Bristol-Myers Squibb

Bristol-Myers Squibb (BMY) has a supplementary Biologics Licensing Application (sBLA) in for its Opdivo to treat hepatocellular carcinoma after previous sorafenib therapy. The application was accepted on May 24 and the FDA granted it priority review status. The application was based on data from the Phase I/II CheckMate -040 clinical trial of Opdivo in advanced HCC patients with and without hepatitis B virus or hepatitis C virus infections. The PDUFA date is September 24.

7. IntelliPharmaCeutics

IntelliPharmaCeutics (IPCI) has a sBLA for Rexista, an abuse-deterrent oxycodone hydrochloride extended release tablet used to treat pain. It has a PDUFA date of Sept. 25. However, on July 26, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committees voted 22 to 1 against approval of the drug.

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