Drug Watch

Bimekizumab is now the first and only approved IL-17A and IL-17F inhibitor for this indication.

The advancement is based on previous observations of preliminary clinical efficacy. There are currently no FDA-approved therapies for this patient population.

Approval is based on data from Bristol Myers Squibb’s CheckMate – 76K trial.

Aaron Farberg, MD, and Shanna Miranti, MPAS, PA-C, discuss the upcoming approvals of nivolumab and IDP-126.

New data from ADORING 1 and ADORING 2 show a rapid reduction in pruritus relief as early as 24 hours after the first application.

Longer-term use of povorcitinib demonstrated further improvement in total body and facial repigmentation.

Protagonist Therapeutics has just announced the company's eligibility to receive $60 million of milestone payments for JNJ-2113 to enter into clinical development programs led by Janssen.

The designation now applies to all approved indications, which includes dermatologic conditions such as psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa.

Abeona Therapeutics is seeking Priority Review and approval of the therapy for patients with recessive dystrophic epidermolysis bullosa.

The IL-17A inhibitor did not meet its phase 2b/3 clinical trial primary end point.

The submission follows the announcement of recent long-term data of the drug in patients ages 6 years and older.

Both companies are hoping to make a positive impact in the neoadjuvant setting of cutaneous squamous cell carcinoma.

V940-001 is the first phase 3 study of a planned comprehensive clinical development program initiated after the positive primary analysis of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial.

Both therapies for alopecia areata and completely resected stage IIB/C melanoma could be approved by the EC for patients aged 12 years or older.

Verrica’s VP-102 is the first FDA-approved treatment for molluscum lesions.

The goal of a January 5, 2024, PDUFA date for berdazimer gel, 10.3%, continues with pre-approval inspection already complete.

AB-101a is a new topical treatment being investigated for mild, moderate, and severe atopic dermatitis and its immune system component.

Coverage for eligible patients began July 12, 2023.

The TRuE-AD3 study met its primary endpoint of IGA-TS improvement from baseline at week 8.

Based on the positive topline phase 3 results, Journey Medical plans to submit a New Drug Application to the FDA in the second half of 2023.

New pharmacokinetic phase 3 data will be presented at the 2023 Society for Pediatric Dermatology meeting next week.

It was found that cancer treatment, pediatric population, and coverage restriction of reference products were revealed as some of the strongest factors associated with biosimilar coverage decisions by US commercial health plans relative to reference products.

Boehringer Ingelheim’s Cyltezo is the first and only FDA-approved interchangeable biosimilar to adalimumab.

Sanofi’s investigational anti-OX40-ligand monoclonal antibody showed statistically significant improvement in signs and symptoms of AD in adults.

The Act4Biosimilars Action Plan aims to highlight key challenges preventing patient access to biosimilars and outline steps to help overcome them.