Drugs

Ipsen Plans Palovarotene NDA After Post Hoc Analysis

Ipsen says it is planning to submit an NDA for palovarotene and its use in treating patients with fibrodysplasia ossificans progressiva (FOP). The submission will be based on data from the MOVE trial, a multicenter Phase 3 study. Earlier, dosing in the trial was paused when futility criteria were met at a pre-specified interim analysis, but a recent post hoc analyses showed the retinoic acid receptor y agonist palovarotene reduced mean annualized new heterotopic ossification (HO) volume in pediatric and adult participants with FOP, Ipsen says. The data were compared with untreated patients from a natural history study over 24 months.

Specifically, the data show that palovarotene-treated patients saw a 62% reduction in mean annualized new HO volume versus untreated patients. Palovarotene safety data were otherwise generally consistent with the known adverse event profile of retinoids, the company says.

It describes FOP as an ultra-rare, genetic disorder that is characterized by HO, formation of bone in soft and connective tissues. Ipsen says HO is permanent and leads to severe functional limitations in joint mobility, progressive and cumulative disability and to shortened life expectancy.

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