As the holidays approach, the U.S. Food and Drug Administration (FDA) is getting in a few drug approvals to wrap up the year. This week there are two decision dates, with another that has been delayed for several months. Here’s a look.
As the holidays approach, the U.S. Food and Drug Administration (FDA) is getting in a few drug approvals to wrap up the year. This week there are two decision dates, with another that has been delayed for several months. Here’s a look.
ADMA Biologics and its Bivigam
ADMA Biologics, with sites in Ramsey, NJ and Boca Raton, Fla., has a drug, Bivigam, which is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency, which includes several diseases such as agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. The FDA approved Bivigam on December 19, 2012, for Biotest Pharmaceuticals Corporation. In December 2016, Biotest stopped production. ADMA Biologics picked up all rights to Bivigam on June 6, 2017, when it acquired the Biotest Therapy Business Unit. ADMA then optimized the production process for Bivigam and submitted a Prior Approval Supplement to the FDA for the drug in June 2018. The FDA has a target action date of December 18 for Bivigam. If approved, ADMA plans to relaunch the drug for commercial sale in the first half of 2019.
Ligand Pharma and Sage Therapeutics’ NDA for IV-Brexanolone
In May, the FDA accepted Ligand Pharmaceuticals and SAGE Therapeutics’ New Drug Application (NDA) for SAGE-547, Sage’s lead product candidate. It is an intravenous formulation of brexanolone for the treatment of postpartum depression (PPD). The target action date is December 19, 2018.
On November 2, the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted 17 to 1 in favor of the drug.
However, on November 20, the FDA extended the PDUFA date for its Priority Review of the NDA. At this point, the product is called Zulresso (brexanolone) injection. The date was moved to March 19, 2019. After the positive FDA Advisory Committee meeting, Sage submitted a proposed Risk Evaluation and Mitigation Strategies (REMS) program with Elements to Ensure Safe Use (ETASU) in response to the FDA’s request. The FDA chose, as it was allowed to do, to give itself another three months to consider the extra materials.
If approved, Zulresso will likely be scheduled by the U.S. Drug Enforcement Administration (DEA) consistent with other approved GABAergic therapies. The DEA will need to issue an interim final rule controlling the drug within 90 days of approval. As of right now, Sage is planning for a June 2019 launch if approved.
Sage licensed SAGE-547 from Ligand Pharmaceuticals.
Jazz Pharmaceuticals and Solriamfetol for Excessive Sleepiness
Jazz Pharmaceuticals has a target action date of December 20 for its NDA for solriamfetol for the treatment of excessive sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA). The agency accepted the NDA on March 2, 2018.
Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) being developed for excessive sleepiness in patients with narcolepsy, OSA, and Parkinson’s disease. Jazz acquired the license to the drug from Aerial Biopharma in 2014. Jazz has worldwide development, manufacturing, and commercialization rights to the drug except for certain Asian jurisdictions. The discoverer of the drug, SK Biopharmaceuticals, maintains rights in 12 Asian markets, including Korea, China and Japan.
“We believe this medicine will provide a meaningful option for patients living with excessive sleepiness due to narcolepsy or OSA, and we look forward to working with the FDA during the review process for solriamfetol,” said Karen Smith, executive vice president, R&D and chief medical officer of Jazz, in a March statement. “Jazz continues to invest in ongoing research, education and advocacy on behalf of the sleep community, including studying solriamfetol for the treatment of excessive sleepiness in other areas of unmet need, such as Parkinson’s disease.”
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