Drugs

PharmaEssentia BLA for Polycythemia Vera Therapy

FDA has accepted for review a PharmaEssentia BLA for ropeginterferon alfa-2b (P1101), a novel pegylated interferon intended for treating rare blood cancer polycythemia vera in the absence of symptomatic splenomegaly. Polycythemia vera begins in a disease-initiating stem cell in the bone marrow that results in a chronic red blood cell increase. The company says it expects an agency decision in early 2021.

The structurally novel monopegylated proline interferon is described as having been designed for administration once every two weeks. The submission is based on data from the Phase 3 PROUD/CONTI-PV clinical trial, which the company says “demonstrated that the investigational treatment offered high and durable hematologic responses and symptom control with good tolerability and low rates of depression observed, with effects on relevant [myeloproliferative neoplasms] mutations supporting a potential disease modifying capability.” It says that response rates steadily increased in ropeginterferon alfa-2b-treated patients throughout 24 months of treatment and remained constant after 36 months.

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