Drugs

Kiniksa Pharma’s Arcalyst OK’d for Pericarditis

FDA has approved a Kiniksa Pharmaceuticals NDA for Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older. Recurrent pericarditis involves inflammation of the pericardium, a thin tissue sac surrounding the heart, which can cause chest pain, an agency release says.

Approval was based on data from an 86-patient trial and the primary effectiveness endpoint was the time to first pericarditis recurrence. “Results showed that 23 (74%) patients in the placebo arm had a recurrence compared to two (7%) patients on Arcalyst, both of whom had temporarily stopped treatment,” FDA says. “Serious, life-threatening infections have been reported in patients taking Arcalyst.” Patients with an infection should not take the drug, and they should avoid live vaccines while taking the drug.

Arcalyst was first approved in 2008 to treat cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome, and Muckle-Wells syndrome in patients 12 years and older.

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