Drugs

Medimetriks Cutting Phase 3 Enrollment After FDA Meeting

Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treatment of mild to moderate atopic dermatitis (AD). Based upon the response, Medimetriks says it is preparing to conduct a single pivotal trial in the U.S. for an NDA, which will be supported by data from already-completed Phase 3 trials conducted in Japan. Earlier this year Medimetriks announced that Otsuka Pharmaceutical achieved positive results in two Phase 3 difamilast clinical trials conducted in Japan in adult and pediatric patients with AD.

Based upon FDA’s recent guidance and a recent end-of-Phase 2 meeting, Medimetriks says it will also reduce the size of its Phase 3 pivotal trial program by about 80%, from the prior total of 1,578 patients across two pivotal trials to a projected total of 336 patients in a single pivotal U.S. trial.

Difamilast is an investigational non-steroidal topical anti-inflammatory PDE4 inhibitor. The company says it believes the drug exerts anti-inflammatory action by inhibiting the production of cytokines and chemical mediators thought to cause the signs and symptoms of atopic dermatitis.

Medimetriks has exclusive U.S. rights to develop and commercialize difamilast, which was discovered by Otsuka.

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