Update on Drugs & Devices: September-October 2020

Trade Name: Tremfya^®
Company: Janssen Pharmaceuticals

Approval Dates/Comments: The US FDA approved an additional indication for this interleukin-23 receptor inhibitor in July 2020 for treating adults with active psoriatic arthritis. In two phase 3 clinical trials, guselkumab achieved the American College of Rheumatology 20% (ACR20) improvement mark at 24 weeks, with 52% and 64% of patients achieving an ACR20 response compared to 22% and 33% of placebo, respectively.

Trade Name: Hulio^®
Company: Mylan/Fujifilm Kyowa Kirin

Approval Dates/Comments: In July 2020, the FDA approved this biosimilar referencing Humira^® (adalimumab, AbbVie) across eligible indications including plaque psoriasis and psoriatic arthritis.

Trade Name: Qwo™
Company: Endo International

Approval Dates/Comments: The FDA approved collagenase clostridium histolyticumaaes) in July 2020 for the treatment of moderate-to-severe cellulite in the buttocks of adult women. This drug enzymatically releases the fibrous septae that pull the skin to the muscle fascia resulting in the characteristic dimpling appearance of cellulite.

Trade Name: ER-004
Company: EspeRare Foundation

Approval Dates/Comments: In July 2020, the FDA granted Breakthrough Therapy designation for the investigational ER-004 protein replacement therapy for the prenatal treatment of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), a life-threatening rare genetic condition. XLHED affects ectodermal structures including sweat glands, respiratory glands, skin, hair and teeth.

Trade Name: Keytruda^®
Company: Merck

Approval Dates/Comments: The FDA approved an additional indication for this programmed death receptor-1 (PD-1)-blocking antibody in June 2020 as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Trade Name: Zilxi™
Company: Menlo Therapeutics

Approval Dates/Comments: The FDA approved minocycline 1.5% topical foam in May 2020 for the treatment of inflammatory lesions of rosacea in adults. This approval marks the first minocycline product to be approved by the FDA for use in rosacea.

Trade Name: ATR-12
Company: Azitra, Inc.

Approval Dates/Comments: In May 2020, the FDA granted Rare Pediatric Disease designation to ATR-12 for the treatment of Netherton syndrome (NS), a rare autosomal recessive disease of the skin, characterized by severe inflammation, pruritus, scaling, redness, and dehydrated skin. ATR-12 is a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of LEKTI protein.

Trade Name: Dupixent^®
Company: Regeneron/Sanofi

Approval Dates/Comments: The FDA approved dupilumab in May 2020 for treating children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent® is the only biologic approved for this population.

Trade Name: Koselugo™
Company: AstraZeneca/Merck & Co.

Approval Dates/Comments: The FDA approved this inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) in April 2020 for the treatment of pediatric patients aged ≥2 years with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). This is the first regulatory approval of a therapeutic agent to treat NF1 PN.