Drugs

Genentech Optic Nerve Rare Disease Drug Approved

FDA has approved a Genentech BLA for Enspryng (satralizumab-mwge) for treating neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – those who are anti-aquaporin-4 antibody-positive. NMOSD is a central nervous system rare autoimmune disease that largely affects the optic nerves and spinal cord. “In patients with NMOSD, the body’s immune system mistakenly attacks healthy cells and proteins in the body, most often those in the optic nerves and spinal cord,” an FDA release says. “Individuals with NMOSD typically have attacks of optic neuritis, which causes eye pain and vision loss. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks.”

Approval was based on data from two 96-week clinical studies. In the first study of 95 adult patients, treatment with Enspryng reduced the number of NMOSD relapses by 74% in patients who were anti-AQP4 positive compared to treatment with a placebo, FDA says. The second study included 76 adult patients and showed that Enspryng reduced the number of relapses in the target population by 78% compared to placebo. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative in either trial, it adds.

Additionally, FDA says the approval required a warning for increased risk of infection, including serious and potentially fatal infections (potential reactivation of hepatitis B and tuberculosis). Other drug-associated warnings and precautions include elevated liver enzymes, decreased neutrophil counts and hypersensitivity reactions.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome