Drugs

AbbVie Rinvoq sNDA Review Extended 3 Months

FDA has extended by three months its review of an AbbVie supplemental NDA for Rinvoq (upadacitinib) and its use in treating adult patients with active psoriatic arthritis. FDA approved Rinvoq in 2019, a once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbuster rheumatoid arthritis drug Humira (adalimumab). The updated user fee review action date is expected late second quarter this year.

AbbVie says it recently received an information request from the agency for an updated benefit-risk profile and assessment in psoriatic arthritis patients. It responded to the request and FDA now says it will require additional time for a full submission review. Separately, the company says it received a similar request from the agency related to an sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted shortly.

As a drug class, Janus kinase inhibitors have received increased FDA safety scrutiny over the past few years. In February, FDA said in a safety communication that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Pfizer’s arthritis and ulcerative colitis drug Xeljanz (tofacitinib) and Xeljanz XR, compared with tumor necrosis factor inhibitors (see story). And late last year, Gilead Sciences and Galapagos said they were scrapping the U.S. development of Jyseleca (filgotinib) for rheumatoid arthritis (RA) after a recent meeting with FDA to discuss an 8/18/2020 NDA complete response letter over testicular toxicity concerns. FDA told the companies that “substantial additional clinical studies” would be required to support a 200mg dose. Filgotinib is approved and marketed in Europe and Japan for treating adults with moderately to severely active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs.

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