Drugs

Another Sponsor Quits Over Post-marketing Study Disagreement

For the second time in three days, an accelerated approval application has been withdrawn due to disagreements with FDA over confirmatory/post marketing study commitments. On 1/28, Regeneron Pharmaceuticals and Sanofi withdrew their supplemental BLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer because they were unable to “align on certain post-marketing studies” with the agency. Earlier this week, Incyte said that after discussions with FDA, it has made a business decision to withdraw its NDA for parsaclisib to treat patients with three forms of lymphoma because the confirmatory studies FDA sought could not be completed within a period that would support the investment (see story).

Recently, FDA commissioner nominee Robert Califf said he’s a “fan” of the accelerated approval process but wants to see changes to speed confirmatory trials to determine if therapies that are given accelerated approval deliver the benefit they claim (see story). Speaking as a member of a panel on accelerated approval at the 1/9 UCSF-Stanford Center of Excellence in Regulatory Science and Innovation “Innovations in Regulatory Science” summit, Califf said accelerated approval was a topic of discussion in his meetings with many senators as part of the confirmation process.

During his confirmation hearing last month (see story), Califf was asked by Senator Richard Burr (R-NC) for assurances that FDA’s accelerated approval program will not be watered down due to recent criticisms in the wake of Biogen’s approved Alzheimer’s drug Aduhelm (aducanumab). He again offered his support of the program, adding: “Accelerated pathway means that we’re accepting that there's more uncertainty, and the FDA has tremendous latitude about the decision it makes with those pathways. That means we got to have a better system to evaluate these products as they're used on the market, and I think there are ways that we can do that now. Technology is making this possible in a way that just wasn't possible before.”

FDA Webview asked the agency to comment on whether stricter post marketing commitments are now being sought from companies seeking accelerated approval, but at press time no response had been received.

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