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Latest From Sue Sutter
But Patent Trial and Appeals Board must issue final written decision on all claims raised by challenger – not just some of them, court says; rulings in two closely watched cases mean that IPR proceedings can continue unabated, but generic drug and biosimilar sponsors may need to rethink how they go about challenging innovator patent claims.
Despite concerns about small size of safety database, Arthritis Advisory Committee endorses 2 mg dose; panel recommends against approval of 4 mg dose due to stronger thrombosis signal in clinical trials, brushing back Lilly's attempt to position the higher dose as having a positive benefit-risk profile in patients with more refractory disease.
Agency remains skeptical of JAK inhibitor's risk/benefit profile in rheumatoid arthritis even after Lilly submitted Sentinel network data showing baricinitib does not present an increased risk of thromboembolic events among RA patients; review documents suggest need to show an efficacy or safety benefit relative to other RA treatments, particularly Pfizer's Xeljanz.
Expanded access program for rare pediatric disease treatment did not enroll many patients due to clinician community overwhelmed by patient demand and questions over who would pay ancillary drug costs.
Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.
Information about an investigational drug and companion in vitro diagnostics may be submitted in a single investigational new drug application to the agency's drug or biologics centers, eliminating the need for a separate submission to the device center – unless the diagnostic is determined to be a serious risk, FDA says in draft guidance.