September 26th 2023
Abeona Therapeutics is seeking Priority Review and approval of the therapy for patients with recessive dystrophic epidermolysis bullosa.
September 12th 2023
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.
August 1st 2023
Both companies are hoping to make a positive impact in the neoadjuvant setting of cutaneous squamous cell carcinoma.
July 27th 2023
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.
Malignancy Risk Low in Secukinumab Treatment
A study finds low risk of malignancy from secukinumab treatment for psoriasis, psoriatic arthritis and ankylosing spondylitis patients, despite limited data.
Study Confirms Safety Profile of Baricitinib Dose for Atopic Dermatitis
Initial rates of common treatment-emergent adverse events from baricitinib 2 mg appear to remain stable or decrease with prolonged exposure.
Phase 2b Trial of Topical Isotretinoin for CI Reaches 50% Enrollment
Timber Pharmaceuticals's phase 2b trial of isotretinoin for congenital ichthyosis (CI) has reached 50% enrollment.
Baricitinib Shows Hair Regrowth in Phase 3 Study for AA
Eli Lilly and Incyte announce results from its phase 3 study evaluating baricitinib 2 mg and 4 mg for the treatment of alopecia areata, making it the first Phase 3 study with top-line results in patients with the hair disorder.
Risankizumab Submitted for Regulatory Approval to FDA, EMA for Psoriatic Arthritis
AbbVie announces the submission of regulatory filings for risankizumab to the FDA and EMA seeking approval for the drug as a treatment for psoriatic arthritis.
April FDA Approvals to Watch
Explore the dermatologic drugs the FDA will make a decision to approve during April 2021.
FDA Approves Cemiplimab for Advanced Basal Cell Carcinoma
The FDA has approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.
Topical minocycline for rosacea now available
ZILXI (FMX103, VYNE Therapeutics), a 1.5% topical minocycline foam, is now available for prescription for the treatment of inflammatory lesions of rosacea in adult patients.
FDA, EMA accepts marketing applications for bimekizumab in psoriasis
UCB announces the U.S. Food and Drug Administration and the European Medicines Agency have accepted the Biologics License Application and Marketing Authorization Application for bimekizumab for the treatment of moderate-to-severe plaque psoriasis in adults.
Sonelokinab demonstrates positive results in phase 2 psoriasis study
Merck announces positive results from its phase 2b trial evaluating sonelokinab, an investigational anti-IL-17 A/F nanobody, in adult patients with moderate-to-severe chronic plaque psoriasis.
FDA accepts NDA filing for topical papulopustular rosacea treatment
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for Sol-Gel’s Epsolay, a 5% microencapsulated benzoyl peroxide cream for the treatment of inflammatory lesions of rosacea or papulopustular rosacea.
Spartalizumab phase 3 combination study fails to meet primary endpoint
Novartis announces their phase 3 study investigating spartalizumab (PDR001) in combination with dabrafenib (Tafinlar) and trametinib (Mekinist) failed to meet its primary endpoint.
MC2 Therapeutics collaborates EPI Health on newly approved psoriasis topical
MC2 Therapeutics and EPI Health announce they have entered into a collaboration agreement for the commercialization of calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora Cream), a newly U.S. FDA-approved topical treatment for plaque psoriasis in adults.
Alembic Pharmaceuticals launches adapalene gel for acne vulgaris
Alembic Pharmaceuticals announces the launch of their bioequivalent and therapeutically equivalent product to Differin Gel 0.3% (Galderma), Adapalene Gel USP 0.3%, a topical retinoid for the treatment of acne vulgaris in patients 12 years and older.
Topical androgen receptor inhibitor approved by FDA for acne
Clascoterone cream 1% (Winlevi, Cassiopea), a first-in-class androgen receptor inhibitor, has been approved by the U.S. FDA for treatment of acne vulgaris in patients 12 years and older.
Mirikizumab beats secukinumab in phase 3 plaque psoriasis study
Eli Lilly’s mirikizumab demonstrates superiority over secukinumab (Cosentyx, Novartis) as a treatment for moderate-to-severe plaque psoriasis, according to recently released results from the OASIS-2 study.
FDA approves ustekinumab for pediatric psoriasis
The U.S. Food and Drug Administration has approved IL-12/IL-23 inhibitor ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson) for treatment of moderate-to-severe plaque psoriasis in pediatric patients 6-11 years.
Cannabinoid products may alter effects of prescription drugs
Researchers have identified and developed lists of medications that may not function properly due to concomitant cannabinoid use in an effort to help medical professionals prescribe prescription drugs safely to their patients.
FDA grants delgocitinib fast track designation for chronic hand eczema
The U.S. Food and Drug Administration (FDA) has granted JAK-inhibitor delgocitinib cream (LEO Pharma) Fast Track Designation for chronic hand eczema.
EC approves secukinumab for pediatric psoriasis
The European Commission has approved secukinumab (Cosentyx, Novartis) for treatment of moderate-to-severe plaque psoriasis in pediatric patients 6<18 years in the European Union.
FDA approves combination treatment for advanced melanoma
The U.S. Food and Drug Administration has approved atezolizumab plus cobimetinib and vemurafenib for treatment of BRAF V600 mutation-positive advanced melanoma. Studies show the combination treatment prolonged patients’ lives by 15 months without disease worsening.
Long-term benefits of pembrolizumab in melanoma
A recently published pooled 10-year analysis shows pembrolizumab demonstrates long-term survival benefits for advanced melanoma patients regardless of BRAF V600E/K mutation status or history of BRAFi, with or without MEKi therapy.
FDA approves plaque psoriasis topical
The U.S. Food and Drug Administration has approved Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%, MC2 Therapeutics) for adult with plaque psoriasis. Wynzora is equipped with the MC2 Therapeutics’ patented PAD Technology and is currently under review in the EU.
FDA approves guselkumab for psoriatic arthritis
Guselkumab becomes the first IL-23 inhibitor approved for treatment of psoriatic arthritis by the U.S. Food and Drug Administration (FDA) following positive phase 3 results from two trials investigating the safety and efficacy of the drug.
Psoriasis biosimilar approved by FDA
The U.S. Food and Drug Administration has approved Mylan and Fujifilm Kyowa Kirin Biologics’ adalimumab-fkjp as a biosimilar to AbbVie’s adalimumab for a variety of inflammatory disease including plaque psoriasis and psoriatic arthritis.
FDA accepts BLA for tralokinumab for atopic dermatitis
The U.S. Food and Drug administration has accepted the Biologics License Application for tralokinumab (LEO Pharma) for moderate-to-severe atopic dermatitis and is expected to make a decision in the second quarter of 2021.
First injectable for cellulite approved by FDA
The U.S. FDA has approved collagenase clostridium histolyticum-aaes (Qwo, Endo International), making it the first FDA-approved injectable treatment for moderate-to-severe cellulite in the buttocks in adult women.
Dupilumab pre-filled pen approved by FDA
The U.S. Food and Drug Administration has approved a single-dose 300 mg pre-filled pen version of dupilumab (Dupixent, Sanofi and Regeneron) for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP) in U.S. patients 12 years and older.
FDA approves new label for sarecycline
Almirall announces the U.S. Food and Drug Administration has approved the updated label for their oral antibiotic sarecycline (Seysara) for treatment of acne vulgaris to help promote the appropriate use of the drug to aid in preventing antimicrobial resistance commonly warned when using antibiotics
Weekly Roundup: June 22-26
ICYMI, this week’s edition features a video series on social media use in dermatology, the launch of our new podcast, as well as articles about FDA approvals for acne and cSCC, progress in epidermolysis bullosa, new rosacea management treatment, plus more.
2 Clarke Drive Cranbury, NJ 08512