As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable.
Eli Lilly and Co.’s $1.1 billion acquisition of Dermira Inc. early last year is looking like a smart move after the company’s atopic dermatitis (AD) drug, lebrikizumab, hit all its targets in two phase III trials. Lebrikizumab is an interleukin-13 antagonist and is part of Lilly’s strategy to build a dermatology portfolio to compete in a market dominated by Sanofi SA and Regeneron Pharmaceutical Inc.’s Dupixent (dupilumab), which was the first injected antibody drug available for AD in 2017. Lilly picked up Dermira, of Menlo Park, Calif., along with lebrikizumab in January last year shortly after the FDA granted lebrikizumab fast track status, paving the way for a potential six-month review.
Riding high on dramatic phase Ib results with KIT receptor-binding monoclonal antibody CDX-0159 in urticaria (hives), Celldex Therapeutics Inc. plans to begin phase II work in the first half of next year. Shares of Hampton, N.J.-based Celldex (NASDAQ:CLDX) closed July 12 at $40.67, up $8.26, or 25%, as Wall Street reacted to favorable data from the trial in antihistamine-refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria (CindU).
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
Rapt Therapeutics Inc. CEO Brian Wong said RPT-193 monotherapy in atopic dermatitis (AD) “looks really promising, but there’s still quite a bit to learn” about the small molecule, designed to inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4. Investors saw enough to push the shares of South San Francisco-based Rapt up 115.5%, or $21.45, to close at $40.02, after trading as high as $41.99 during the day.
Dermavant Sciences Inc. has announced a $200 million financing deal to clear the way for a potential U.S. launch of its dermatology cream tapinarof, covering a potential milestone payment to Glaxosmithkline plc following a filing in severe psoriasis.
Kyowa Kirin Co. Ltd. has partnered with Amgen Inc. to jointly develop and commercialize KHK-4083, Kyowa Kirin’s phase III-ready anti-OX40 fully human monoclonal antibody for the potential treatment of atopic dermatitis. Kyowa Kirin will receive a $400 million up front, while milestone payments could add an additional $850 million. Significant royalty payments on future global sales could sweeten the blockbuster deal.
HONG KONG – Olix Pharmaceuticals Inc. has entered an extensive research collaboration to test its RNAi therapeutic, OLX-104C, with Fimanac, PCI Biotech Holding ASA’s delivery technology for nucleic acid-based therapies, with the aim of reducing off-target effects while treating androgenic alopecia, or hair loss.
The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month.