Becoming the first approved treatment for chronic hand eczema in the U.S., Leo Pharma A/S’s Anzupgo (delgocitinib) received FDA clearance for an indication that affects 10% of adults worldwide. The cream, dosed at 20 mg/g and applied topically, will treat moderate to severe cases in those not responsive to, or unable to take, topical corticosteroids.
Apogee Therapeutics Inc. plans to enter a crowded atopic dermatitis market with established drugs, such as Dupixent (dupilumab, Regeneron Pharmaceuticals Inc. and Sanofi SA) and Ebglyss (lebrikizumab-lbkz, Eli Lilly and Co.), which are sold by much larger competitors. But the company thinks it can compete with its anti-IL-13 antibody, APG-777, thanks to the drug’s 77 day half-life that may allow it to be dosed only two to four times a year in the maintenance phase, compared to 13 to 26 injections per year for the established competitors.
Atopic dermatitis data from Nektar Therapeutics Inc. put investors even more in the mood for further results with rezpegaldesleukin (rezpeg), an IL-2 pathway agonist and regulatory T-cell proliferator, also in the works for severe to very severe alopecia areata.
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris.
Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris.
Backers of Jena, Germany-based Inflarx NV have turned their attention to the rest of the pipeline after the stock-jolting news from an independent data monitoring committee (DMC) responsible for the unblinded interim analysis of the phase III trial with vilobelimab in pyoderma gangrenosum (PG). The panel recommended stopping the trial due to futility, although no adverse events were noted in the analysis, which was carried out on the first 30 patients who signed up for the experiment.
Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
Barely a year after the U.S. FDA shackled Abeona Therapeutics Inc.’s cell-based gene therapy with a complete response letter, the agency has approved it for treating a rare and genetic skin disease. Zevaskyn (prademagene zamikeracel), for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa, will be priced in the U.S. at $3.1 million.
With a promising IL-36 inhibitor for atopic dermatitis (AD, or eczema) at the phase II stage, Turn Therapeutics Inc. has gained $75 million in post-public commitments and meanwhile is pursuing a grassroots strategy to keep the coffers in balance.
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