Drugs

Advisors to Consider Peanut Allergy Treatment

The FDA Allergenic Products Advisory Committee meets 9/13 to consider Aimmune Therapeutics’ BLA for Palforzia (peanut allergen powder) with a proposed indication to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. In a briefing paper released in advance of the meeting, agency medical reviewers say the drug met its efficacy endpoints in clinical trials, but there were some safety issues.

The reviewers say treatment with Palforzia resulted in an increased risk of allergic reactions, some of which resulted in increased epinephrine use compared to the trial group given a placebo. There also were more trial subjects in the Palforzia arm who discontinued treatment due to side effects than in the placebo arm.

FDA will be asking the committee whether the efficacy and safety data support licensure of Palforzia as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 with a confirmed diagnosis of peanut allergy.

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