Drugs

FDA Declines to Approve Sobi Gout Therapy

FDA has issued Sobi a Complete Response Letter (CRL) on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricase) for treating adults with uncontrolled gout. The letter cited manufacturing-related deficiencies that must be corrected.

The company said FDA requested additional information primarily related to the chemistry, manufacturing and controls (CMC) package for the biologic component of the product and deficiencies identified at contract manufacturing facilities. Importantly, Sobi said the agency did not identify any clinical safety or efficacy issues that would affect the drug's approvability.

The Stockholm-based rare disease company said it plans to request a meeting with FDA to discuss the agency's comments, determine the requirements for resubmission and work with its contract manufacturing organizations to address the identified deficiencies.

The latest CRL adds to a growing number of FDA complete response letters issued over the past year that have centered on manufacturing, chemistry, manufacturing and controls (CMC), or contract manufacturing facility issues rather than clinical data.

NASP is an investigational therapy designed to lower serum uric acid levels in patients with uncontrolled gout through a sequential infusion of two components. The treatment combines nanoencapsulated sirolimus, intended to reduce the formation of anti-drug antibodies, with pegadricase, a uricase enzyme that lowers uric acid levels.

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