China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
Additional data from a phase II trial of S1P modulator icanbelimod (CBP-307) reinforced earlier positive results in ulcerative colitis (UC), potentially putting Connect Biopharma Holdings Ltd. in a better negotiating position as it seeks a partner to take the program forward, while in-house activities remain focused on an early 2024 regulatory filing for atopic dermatitis candidate CBP-201.
Right on schedule the U.S. FDA gave its blessing for Krystal Biotech Inc.’s topical gene therapy, Vyjuvek (beremagene geperpavec, or B-VEC), an orphan drug, to become the first approved treatment for the rare skin condition dystrophic epidermolysis bullosa (DEB).
A heart-protective cardiac myosin inhibitor and two biologics – one for a type of non-Hodgkin lymphoma and another for an inflammatory skin condition – were among the therapies recommended for approval by the EMA’s Committee for Medicinal Products for Human Use this week.
New and updated clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Abbvie, Acelyrin, Arcutis, Concert, Connect, Galderma, Incyte, Inmagene, Leo, Nimbus, Regeneron, Sanofi, Sun, Takeda, UCB.
Takeda Pharmaceutical Co. Ltd.’s oral allosteric tyrosine kinase 2 inhibitor TAK-279 (formerly NDI-034858) met primary and secondary endpoints in a phase IIb clinical trial in patients with moderate to severe plaque psoriasis, but analysts say it may be too little too late to make a big splash compared to competitors.
Protagonist Therapeutics Inc. got a win in its phase IIb study and is making plans for a phase III. JNJ-2113 (formerly PN-235), an oral, interleukin-23 receptor antagonist peptide, hit its primary efficacy endpoint in treating moderate to severe plaque psoriasis. A statistically significant greater proportion of the participants receiving JNJ-2113 saw a 75% improvement in their skin lesions compared to placebo at week 16.
Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023.
Biocryst Pharmaceuticals Inc.’s unveiling of real-world data Feb. 24 with its approved Orladeyo (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) brought more attention to the space, due to yield findings from would-be competitors in the near term.