FDA News Roundup: Baxter, Mylan, Shire, And More

FDA Advisory Committee Says Yes To Natpara

NPS Pharmaceuticals received a nod of approval from an FDA Advisory Committee for its Hypoparathyroidism disorder drug, Natpara. The endocrine disorder, which is characterized by insufficient levels of parathyroid hormone (PTH), was treated by the drug in the Phase 3 REPLACE trial. Natpara has received orphan drug designation from the FDA for Hypoparathyroidism. The EMA also designated Natpara an orphan drug under the name Natpar. The FDA is expected to make its decision by the end of October. 

Baxter’s HyQvia Wins FDA Approval

Baxter and Halozyme received some good news from the FDA when the regulatory agency granted approval to the companies’ subcutaneous treatment for adults with primary immunodeficiency (PI). HyQvia (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase) is an infusion received once every three to four weeks in one injection —  a cut above the current standards of treatment that often require weekly or bi-weekly treatment.  The infusion is created out of human plasma and combined with Hyaluronidase to increase the dispersion and absorption of the immune globuline infusion 10%. 

Whooping Cough Drug Designated Orphan Drug

A new treatment for Whooping Cough (Pertussis) developed by Synthetic Biologics received orphan drug designation. The drug, known as SYN-005, is a monoclonal antibody combination that targets and neutralizes the pertussis toxin, in turn cutting down on risk of morbidity and death in infected infants. There are roughly 300,000 infant deaths each year, often due to a lack of vaccination. The company plans to file an Investigational New Drug application for the drug midway through 2015.

FDA Accepts Vernalis’, Tris’ NDA Filing For Review

The FDA has accepted and plans to review the NDA for Vernalis’ cough medicine Tuzistra XR (CCP-01). The FDA will make its decision by the end of April, 2015. The acceptance of the application has triggered a milestone payment from Vernalis to Tris Pharma, who entered a licensing agreement in 2012 for six extended release equivalents to current immediate release prescription cough medications. Tuzistra XR is the first product in this pipeline to achieve an NDA filing.

Mylan HIV Combo Achieves Tentative Approval

Mylan was given FDA tentative approval for its combination emtricitabine and tenofovir disoproxil fumarate tablets (220 mg/300 mg) that are co-packaged with nevirapine tablets (200 mg). The combination of emtricitabine and tenofovir — the generic of Gilead’s Truvada — is indicated for patients with HIV-1, either as a monotherapy or in combination with other antiretrovirals for HIV-1 patients 12 years and older. While this tentative approval means that the product has met quality, safety, and efficacy requirements, because of existing patent protections, the drug is not permitted for marketing in the U.S.

FDA Accepts Shire sNDA For Priority Review

Shire’s supplemental New Drug Application (sNDA) for Vyvance (lisdexamfetamine dimesylate) capsules was accepted for filing and granted priority review. The FDA will announce its decision in February, 2015. The company hopes that the FDA will approve the drug for adults with binge eating disorder (BED). Vyvance, which is a federally controlled substance (CII) because of its abuse-enabling properties, has already been approved in the U.S. as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). Shire held two phase 3 studies evaluating the drug as a treatment for BED and determined that the drug significantly lowered the number of days of binge eating per week when compared to placebo.

NovaBiotics Lyvonex Named Orphan Drug In CF

A new Cystic Fibrosis (CF) drug, Lynovex, was designated an orphan drug last week. The drug is currently being developed by NovaBiotics in both tablet and dry inhaled powder formulations to be used in the case of acute exacerbations and for chronic and maintenance CF treatment. The drug is designed to not only break down the mucus that blocks CF patients’ airways, but it also has the ability to prevent infections and halt the growth of biofilms in the CF airway. Patients are currently being dosed in a recently launched phase 2a clinical trial in the U.S. for the oral formulation of Lynovex, with trials of the inhaled formulation expected to begin in 2015. The U.K. and Europe also have plans to launch phase 2b trials in 2015.