Drugs

MediciNova ALS Pivotal Trial Gets FDA Backing

FDA has given approval for MediciNova to proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) patients. If the pivotal trial is successful, data will be used to support a future NDA, according to the company. FDA concurred, it says, on the trial’s design, which includes the following elements:

Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-166 (ibudilast) vs. placebo in about 150 ALS patients in the U.S.;
Patients will be randomized 1:1 to receive either 100 mg/day MN-166 (ibudilast) or placebo for nine months;
The primary endpoint is the mean change in functional activity at nine months as measured by the ALSFRS-R score (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised);
Secondary endpoints include mean change from baseline of muscle strength and quality of life, the utilization of and time to clinically indicated prescription for non-invasive ventilation, safety and tolerability.

MediciNova adds that major inclusion criteria for trial eligibility will include ALS onset no more than 18 months before screening, at least one documented ALSFRS-R score between three and six months before screening, use of riluzole for at least 30 days before initiation of study drug, and total ALSFRS-R score of at least 35 at screening.

Ibudilast is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor inhibitor and phosphodiesterase -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors, the company says. “It attenuates activated glial cells, which play a major role in certain neurological conditions,” it says.

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