Drugs

Immunic Reports Positive Data on MS Drug

Immunic says “positive” data from the Phase 2 CALLIPER trial of nuclear receptor related 1 (Nurr1) activator vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS) showed the therapy reduced the relative risk of 24-week confirmed disability worsening (24wCDW) events by 20% compared to placebo. “Further analyses by disease subtype demonstrated that vidofludimus calcium was associated with a 30% reduction in the relative risk of 24wCDW events in the primary progressive multiple sclerosis (PPMS) study population (n=152) compared to placebo and a respective 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) study population (n=268),” it adds.

The company says reducing confirmed disability worsening is widely considered to be the most recognized regulatory approval endpoint for registrational studies in progressive forms of multiple sclerosis (MS). “In support, the evidence of focal inflammatory disease (gadolinium-enhancing lesions at baseline in 6.8% of naSPMS and 17.8% of PPMS patients) and the number of on-study relapses (5.8% in the overall patient population) are lower than in most historical PMS trials,” it adds.

A key unmet need in MS continues to be the lack of safe and effective therapies that can slow or halt disease progression, according to Immunic. Because vidofludimus calcium has been shown to be a potent activator of Nurr1, which plays a key role in neuroprotection, it could become the first real neuroprotective treatment option for patients with progressive forms of MS, the company 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

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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