Drugs

Bellerophon, FDA Agree on INOpulse Approval Pathway

Bellerophon Therapeutics and FDA have reached agreement on the regulatory approval pathway for INOpulse, a proprietary pulsatile nitric oxide delivery system for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Based on recent data and INOpulse’s safety profile, Bellerophon says FDA agreed that it can measure moderate to vigorous physical activity (MVPA) as the primary endpoint in its planned pivotal Phase 3 study. MVPA will be measured by a medical wearable continuous activity monitor (actigraphy), the company says. In addition, the agency agreed with the company’s proposal that a Phase 2b study be amended to a Phase 2/3 trial. “This agreement allows a seamless transition into Cohort 3 of iNO-PF, which will serve as the pivotal Phase 3 trial,” the company says.

In January, Bellerophon reported positive results from Cohort 1 of its ongoing Phase 2b iNO-PF trial. “Subjects on active treatment demonstrated a statistically significant improvement of 34% in MVPA as compared to subjects on placebo, as well as improvements in overall activity, oxygen saturation and additional functional measures,” the company says. “Compared to surrogate endpoints, such as six-minute walk distance or patient reported outcomes, change in MVPA provides a direct and continuous measure of physical activity in PH-ILD patients, who have limited ability to perform even the most basic daily tasks.”

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