FDA Action Alert: Sanofi, Alkermes, Andor and More

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Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA)

Sanofi Pasteur’s Fluzone Quadrivalent Flu Vaccine

Sanofi Pasteur had a target action date of Monday, January 28 for its Fluzone Quadrivalent Influenza Vaccine. It is for a supplemental Biologics License Application (sBLA) to include children 6 through 35 months of age. The agency approved the vaccine in the 0.5 mL dose for that age group on January 23. The company indicates it will also have the 0.25 mL dose available for the 2019-20 flu season for the expanded age range.

During the 2017-2018 flu season, the Centers for Disease Control and Prevention (CDC) confirmed 185 influenza-related pediatric deaths.

“Offering pediatricians the convenience of the same 0.5 mL dose option for children, may help streamline immunization efforts,” stated David P. Greenberg, Regional Medical Head North America, Sanofi Pasteur. “The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering.”

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Alkermes and ALKS 5461 for Major Depressive Disorder

Alkermes has a target action date of Thursday, January 31 for its ALKS 5461 for adjunctive treatment of major depressive disorder (MDD) in patients with inadequate response to standard antidepressant treatments. On November 1, 2018, the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted not to recommend the drug. The vote was 2 for and 21 opposed. Although the FDA is not required to follow the recommendations of the Adcoms, they typically do.

ALKS 5461 missed targets in two late-stage trials in 2016, but another Phase III trial later in that year showed the drug significantly reduced symptoms of depression with patients with MDD compared to placebo. 

“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the Advisory Committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants,” stated Richard Pops, Alkermes’ chief executive officer. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”

Andor Pharmaceuticals’ Generic to J&J’s Concerta for ADHD

Andor Pharmaceuticals has a target action date of Friday, February 1, for its methylphenidate hydrochloride extended-release tablets, a generic version of Janssen’s Concerta for attention deficit hyperactivity disorder (ADHD). On August 3, 2018, Andor signed a licensing deal with Lannett Company for Lannett to market the drug, once approved.

“We look forward to returning to this AB-rated Methylphenidate market,” stated Tim Crew, Lannett’s chief executive officer. “Based on Andor’s target action date of February 1, 2019, we are optimistic about launching the product well within calendar 2019. The product adds to the sizable number of products we expect to launch in the near term.”

In the 12-month period ending June 2018, total U.S. sales of Methylphenidate Hydrochloride Extended-Release tablets were about $1.8 billion.

Evolus’ Resubmission of a BLA for Jeuveau for Frown Lines

Evolus has a target action date of February 2 for its resubmission of its BLA for Jeuveau (prabotulinumtoxinA) for frown lines. On November 19, the FDA gave conditional acceptance of the Jeuveau brand name and its partnership with The American Society for Aesthetic Plastic Surgery (ASAPS).

“The unveiling of the Jeuveau brand and our partnership with key medical societies are significant milestones as we advance towards commercialization in anticipation of a Spring 2019 U.S. commercial launch,” stated Michael Jafar, Evolus’ chief marketing officer.

The product is the first 900 kDa botulinum toxin since Botox, and in several Phase III trials has demonstrated non-inferiority to Botox.

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