Drug Watch

The US license period will start on February 22, 2025.

The sNDA is supported by positive data from the phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials.

The FDA’s PDUFA target date is May 25, 2024.

One notable change: CVS Caremark has removed the Humira biosimilar Amjevita and now prefers Hyrimoz and an unbranded biosimilar.

Jared Gollob, MD, Chief Medical Officer of Kymera Therapeutics, spoke with Dermatology Times to discuss these trial results.

There are currently no FDA-approved therapies for the rare, genetic disease.

Shawn Kwatra, MD, shares his thoughts on the positive phase 3 data of OLYMPIA 2.

Data from Novartis will be presented at the 2023 American College of Allergy, Asthma, and Immunology Scientific Meeting.

HADLIMA is currently indicated for psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa, among others.

The approved indication makes Wezlana the first approved interchangeable biosimilar to Stelara.

The US Food and Drug Administration has approved IDP-126 gel for patients with acne.

The CRL states that additional efficacy data is needed in order to support approval.

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.