Drugs

Eisai Expects FDA to Approve Alzheimer’s Drug Soon

Eisai CEO Ivan Cheung says the company expects FDA to fully approve its Alzheimer’s drug Leqembi (lecanemab) this summer. In a 2/16 interview with CNBC, Cheung said approval could come as soon as July if the agency gives Leqembi priority review for demonstrating a significant improvement in how early Alzheimer’s is treated.

Cheung said Eisai is in “urgent” talks with the Centers for Medicare and Medicaid Services on its coverage for Leqembi, which the company is pricing at $26,500 a year.

CNBC reports that Medicare published a 4/2022 guidance limiting coverage for Alzheimer’s drugs like Leqembi that use antibody treatment to target the plaque that is thought to cause the disease. Under Eisai’s current accelerated approval status, it says, Medicare would only cover the costs of people in clinical trials approved by FDA or the National Institutes of Health.

Cheung said the $26,500 annual cost should come down over time. He said the treatment is currently administered twice a month but Eisai is planning to file by the end of the next fiscal year for a once-monthly maintenance dose after the first 18 months of regular treatment.

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

Read more

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