Drugs

Pfizer Arthritis Drug Has Small Efficacy, Safety Concerns: FDA

FDA says a Pfizer BLA for osteoarthritis drug tanezumab subcutaneous injection has a modest treatment effect and some safety concerns. In a briefing document released in advance of a 3/24-25 advisory committee meeting, agency reviewers said superior efficacy was not demonstrated with tanezumab over non-steroidal anti-inflammatory drugs (NSAIDs), and two serious toxicities — joint destruction and neuropathy — caused by tanezumab have been identified.

Safety issues appear to dominate the briefing document, with the reviewers saying that the “trajectory of incidence of joint events in patients with more than one year of treatment is unknown. Most of the joint safety events were detected towards the end of the treatment and during the follow-up period after the cessation of treatment... Tanezumab is also associated with an elevated risk of requiring a total joint replacement, as observed in two of the three post-2015 clinical studies, with evidence of dose response... Moreover, there is evidence that the risk for developing joint destruction is two- to three-fold higher if NSAIDs and tanezumab are used concomitantly.”

Additionally, Pfizer has proposed a Risk Evaluation and Mitigation Strategy (REMS), but safety reviewers note it is not sufficient to mitigate the joint risks and would not ensure that the benefits of tanezumab outweigh its risks. They note that discontinuing the drug after patients develop joint damage “does not appear to be effective in preventing further damage to the joints. In addition, the required precision and consistency of the medical imaging and interpretation do not appear feasible in practice.Tanezumab also can cause abnormal peripheral sensation characterized as (predominantly) mild, self-limited mononeuropathy, with the most common manifestation being carpal tunnel syndrome.”

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