Disc Medicine reports the phase 3 APOLLO trial met all primary and secondary end points, with whole-blood PPIX reduced 41.4% vs placebo and an NDA resubmission planned by end of 2026.
|Videos|August 4, 2021
Twyneo Approval Shakes up Acne Treatment World
Author(s)Morgan Petronelli
Joshua Zeichner, MD, associate professor of dermatology and director of cosmetic & clinical research in dermatology, Mount Sinai Hospital, New York, discusses the impact of the recent FDA approval of Twyneo (Sol-Gel) for the treatment of acne.
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The FDA clearance allows Edesa to expand an ongoing placebo-controlled study of the CXCL10 antibody EB06 to US sites, with topline data expected in the fourth quarter of 2027.
The novel oral helicase-primase inhibitor demonstrated significantly higher rates of complete lesion healing compared with investigator’s choice treatment in the phase 3 PRIOH-1 trial.
By week 36, combination therapy altered 482 proteins and 467 genes vs 140 and 16 with ixekizumab alone in exploratory TOGETHER-PsO data.
The supplemental New Drug Application seeks to expand the use of Ameluz with red light photodynamic therapy beyond the face and scalp to actinic keratoses on the extremities, neck, and trunk.
The approval of the oral BTKi rests on a phase 3 result of 29.3% complete response from hives vs 14.0% with placebo at week 12.
Celltrion’s US launch of omalizumab-igec adds an interchangeable biosimilar option for eligible patients with chronic spontaneous urticaria.
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