Drugs

Complete Response Letter to Actelion for Opsumit sNDA

FDA has issued Johnson & Johnson's Actelion Pharmaceuticals a complete response letter for its supplemental NDA for Opsumit (macitentan) for treating adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) to improve pulmonary vascular resistance (PVR) and exercise capacity. The agency said that additional data are needed to evaluate the use of OPSUMIT in treating CTEPH.

Actelion says the proposed new indication is based on investigational data from MERIT-1 (Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension), a Phase 2 study to assess the efficacy, safety and tolerability of macitentan 10 mg in patients with inoperable CTEPH (WHO Group 4).

Opsumit is an orally active endothelin receptor antagonist currently approved in the U.S. for treating pulmonary arterial hypertension to reduce the risks of disease progression and hospitalization. For all female patients, the therapy is available only through a restricted program called the OPSUMIT Risk Evaluation and Mitigation Strategy, which is related to a Boxed Warning for embryo-fetal toxicity.

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