Drug Watch

The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index.

Phase 3 trials have been initiated in patients with high-risk melanoma.

The phase 2 study achieved the primary end point of a >30% Severity of Alopecia Tool score improvement.

The month of May has been full of pipeline news, including updates on VYN201 for nonsegmental vitiligo, imsidolimab for GPP, sonelokimab for HS, and more.

The Lancet data is the primary publication of bimekizumab results from BE HEARD I and BE HEARD II.

The new action date is December 29, 2024.

Scassellati Sforzolini discusses the significance of Galderma’s nemolizumab receiving 4 additional filing acceptances for prurigo nodularis and atopic dermatitis.

VELA is the first phase 3 hidradenitis suppurativa trial to evaluate HiSCR75 as the primary end point.

Bristol Myers Squibb announced 70% of patients maintained significant improvement after 4 years with no new safety concerns.

Acinonyx Bio's topical cream, ACX, targets Propionibacterium acnes.

The results are both confirmatory and extend the response results from a prior phase 3 trial known as FLASH.

The analysis revealed a higher rate of discontinuations due to immune-mediated adverse experiences.

Patients who responded to imsidolimab in GEMINI-1 and who moved into GEMINI-2 maintained clear or almost clear skin.

VYNE expects to enroll the first patient with vitiligo in the phase 2b trial for VYN201 in the second quarter of 2024.

The new research will compare eblasakimab to dupilumab and lebrikizumab.

A decision from the FDA is expected in the second half of 2024.

The FDA’s PDUFA date is expected in quarter 4 of 2024.

In LEVEL-UP, upadacitinib demonstrated superiority over dupilumab in achieving EASI-90 and little to no itch at week 16.

Sixty percent of dupilumab-treated patients with AD treated with 400mg of eblasakimab weekly achieved EASI-90 after 16 weeks.

MoonLake’s sonelokimab is being evaluated for hidradenitis suppurativa, psoriasis, and psoriatic arthritis.

Loretta Fiorillo, MD, FRCPC, reviews key data points from the phase 3 SPROUT study.

The new launch is set to bring berdazimer topical gel, 10.3% to adults and pediatric patients over the age of 1 with molluscum contagiosum faster.

The merger will focus on advancing Oruka’s portfolio of novel biologics for the treatment of chronic skin diseases.

The agreement for a second confirmatory trial comes after a successful phase 3 FLASH study that yielded positive outcomes and efficacy.

The biosimilar landscape experienced significant activity, marked by fresh data from conferences, novel findings regarding adalimumab biosimilars, and more.

Povorcitinib is being evaluated for non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma, and chronic spontaneous urticaria.

If approved, bimekizumab will be the first IL-17A and IL-17F inhibitor approved in Europe for hidradenitis suppurativa.

The FDA has assigned a Prescription Drug User Fee Act target action date for August 13.

The anticipated PDUFA date is November 4, 2024.

Shawn Kwatra, MD, shares positive updates on phase 2 oral povorcitinib for prurigo nodularis at AAD 2024.