Drugs

Roivant/Priovant Report Positive Data on Non-Infectious Uveitis Drug

Roivant and Priovant Therapeutics have announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). The drug met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies, according to the company. It also achieved “statistically significant and clinically meaningful benefit on all key secondary endpoints, including measurements of sustained steroid-free quiescence at Week 48, chorioretinal vascular leakage, resolution of macular edema and patient-reported visual functioning,” it says.

FDA approved brepocitinib (Lisraya) in August as a once-daily oral tablet approved for treating dermatomyositis in adults. Priovant intends to file a supplemental NDA for brepocitinib for treating NIU in the first half of 2027.

NIU is described as a debilitating ocular inflammation and one of the leading causes of blindness among the working-age population. “Undertreated NIU can result in permanent vision loss,” the companies say. “NIU is frequently associated with ocular pain, floaters and visual impairment across multiple domains (acuity, peripheral vision, color recognition, ability to focus on moving objects, night vision, etc.) that can interfere with everyday activities including reading the newspaper, driving, socializing, working and independent self-care.”

Strong Stakeholder Support for PDUFA 8

Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the draft PDUFA 8 commitment letter. The PhRMA comment says PDUFA 8 will help ensure the long-term sustainability of FDA’s human drug review program and strengthen agency capabilities by: * enhancing the efficiency of the drug review process

CDRH on Hiring Spree After Losing 22% of Workforce

CDRH is accelerating hiring after losing about 22% of its workforce over the past year and a half, including up to 30% of its clinical reviewers and significant numbers of artificial intelligence and digital health specialists. CDRH drector Michelle Tarver disclosed the staffing losses 10/21 at AdvaMed's

Bipartisan Policy Center Comment on Generative AI Devices

The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points: * several approaches in

Improve FDA Myelodysplastic Syndromes Guidance

Researchers from Johns Hopkins and the University of Miami say myelodysplastic syndromes (MDS) therapeutic development is challenged by the syndromes’ biological diversity and regulatory risk. Writing in Blood Advances, the researchers say MDS is “ideal for FDA to implement flexible, biology-informed regulatory pathways. Establishing such frameworks in MDS could

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Strong Stakeholder Support for PDUFA 8

CDRH on Hiring Spree After Losing 22% of Workforce

Bipartisan Policy Center Comment on Generative AI Devices

Improve FDA Myelodysplastic Syndromes Guidance