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Guselkumab (Tremfya) Gets CHMP Backing for Plaque Psoriasis

TREMFYA

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the plaque psoriasis drug guselkumab (Tremfya, Janssen-Cilag International NV) for approval. The CHMP supported the use of guselkumab for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy, according to an EMA news …

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Skin Disease Tx Abandoned by Developer

skin disease

Development of the novel treatment for the skin disease epidermolysis bullosa will be discontinued, Amicus Therapeutics, Inc announced. The SD-101 treatment for the rare genetic disease failed to meet primary endpoints in a late-stage trial, Reuters reported, after similar rates of treatment participants achieved wound healing as did placebo. Instead, the drug …

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Risankizumab tops ustekinumab in phase II psoriasis trial

Psoriasis treatment

Key clinical point: Clinical responses in psoriasis patients treated with risankizumab were superior to responses in patients treated with ustekinumab. Major finding: At 12 weeks, 77% of risankizumab patients showed a 90% or greater reduction in PASI score, compared with 40% of ustekinumab patients. Data source: A phase II randomized …

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Dupixent (dupilumab) FDA Approval

dupixent

Company: Regeneron Pharmaceuticals Approval Status: Approved March 2017 Specific Treatments: atopic dermatitis Therapeutic Areas Dermatology General Information Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist. Dupixent is specifically indicated for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. …

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Bavencio (avelumab) FDA Approval

Bavencio avelumab

Company: EMD Serono/Pfizer Approval Status: Approved March 2017 Specific Treatments: Merkel cell carcinoma Therapeutic Areas: Dermatology Oncology General Information Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody. Bavencio is specifically indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma. Bavencio is supplied as a …

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FDA approves new psoriasis drug – Siliq

FDA Approved

The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or …

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Siliq (brodalumab) FDA Approval

Siliq brodalumab

Company: Valeant Pharmaceuticals Approval Status: Approved February 2017 Specific Treatments: plaque psoriasis Therapeutic Areas Dermatology General Information Siliq (brodalumab) is a human interleukin-17 receptor A (IL-17RA) antagonist. Siliq is specifically indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to …

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Rhofade (oxymetazoline hydrochloride) FDA Approval

Rhofade

Company: Allergan Approval Status: Approved January 2017 Specific Treatments: facial erythema associated with rosacea Therapeutic Areas Dermatology General Information Rhofade (oxymetazoline hydrochloride) is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor. Rhofade is spccifically indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Rhofade is supplied as a cream for …

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