Clinical

Articles

Piclidenoson is a first-in-class, A3 adenosine receptor agonist small molecule that inhibits the inflammatory cytokines interleukin 17 and 23.

Novel Psoriasis Therapy to be Submitted to FDA 

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Olumiant is the first systemic therapy available to treat alopecia.


 FDA Approves Olumiant to Treat Patients with Alopecia


Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.


FDA Approves Dupixent for Young Children with Atopic Dermatitis

If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.

FDA Accepts Dupixent Application for Treating Skin Lesions

Deficiencies at the contract manufacturing company are, for the second time, holding up approval of VP-102 to treat molluscum contagiosum, a mild skin infection.

FDA Issues Second CRL for Poxvirus Treatment

Vtama is approved to treat adults with mild, moderate, and severe psoriasis. It is expected to be available in the first week of June 2022.

FDA Approves First Non-Steroid Cream for Psoriasis

Bimekizumab, now called Bimzelx, is a monoclonal antibody being reviewed as treatment for adults with moderate-to-severe plaque psoriasis. 

 FDA Issues CRL for Bimekizumab for Psoriasis

The study aims to generate data related to Tremfya in people of color who have plaque psoriasis.

Janssen to Study Tremfya in People of Color

Opzelura is being reviewed as a treatment for vitiligo, a disease that causes the loss of skin color. The new PDUFA date is July 18, 2022.

FDA Extends Review of Opzelura for Skin Condition

Laura Joszt, MA, is a vice president of content at MJH Life Sciences

 since 2011. She has an MA in business and economic reporting from New York University.

Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.

Dermatology