April 2015 | Volume 14 | Issue 4 | Feature | 427 | Copyright © 2015
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
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FDA Approves Cosentyx for Psoriasis
Novartis has announced that the FDA has approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis in adult patients who require systemic therapy or phototherapy (light therapy). According to Novartis, Cosentyx is the first approved human monoclonal antibody that selectively binds to interleukin IL-17A.
The FDA approval was based on the positive efficacy and safety outcomes from 10 phase II and phase III studies which included over 3,990 adult patients with moderate-to-severe plaque psoriasis. The Phase III clinical program included four placebo-controlled studies which examined Cosentyx 300 mg and 150 mg in patients with moderate-to-severe plaque psoriasis. In these studies, Cosentyx met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator's Global Assessment modified 2011 (IGA) 0/1 responses, showing significant skin clearance at week 12. Cosentyx (300 mg) also maintained its safety profile when compared to Enbrel (etanercept) and Stelara (ustekinumab).
Cosentyx was also recently approved in the EU for the treatment of moderate-to-severe plaque psoriasis in adult patients who require systemic therapy or phototherapy (light therapy. Cosentyx had previously been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Novartis reports that it is also evaluating Cosentyx for the treatment of ankylosing spondylitis and psoriatic arthritis. Regulatory applications for these indications are scheduled in 2015.
Novartis announces FDA approval for first IL-17A antagonist Cosentyx(TM) (secukinumab) for moderate-to-severe plaque psoriasis patients.
Offering a new treatment option for patients, Cosentyx is the first approved human monoclonal antibody (mAb) that selectively binds to interleukin IL-17A.
Phase III data demonstrated Cosentyx resulted in clear or almost clear skin in the majority of patients with moderateto- severe plaque psoriasis
Cobimetinib and Zelboraf (Vemurafenib) in Advanced Melanoma
Genentech has announced that the FDA has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by August 11, 2015.
The NDA is based on results of the coBRIM Phase III study, which showed the MEK inhibitor cobimetinib plus Zelboraf reduced the risk of disease worsening or death by half in people who received the combination (hazard ratio [HR]=0.51, 95 percent confidence interval [CI] 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone. The safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab value abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab value abnormalities.
The coBRIM study is an international, randomized, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of 60 mg once daily of cobimetinib in combination with 960 mg twice daily of Zelboraf, compared to 960 mg twice daily of Zelboraf alone. In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma (detected by the cobas® 4800 BRAF Mutation Test) and previously untreated for advanced disease were randomized to receive Zelboraf every day on a 28-day cycle plus either cobimetinib or placebo on days 1-21. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent. Investigator-assessed PFS was the primary endpoint. Secondary endpoints include PFS by independent review committee, overall response rate, overall survival, duration of response and other safety, pharmacokinetic and quality of life measures.
There was a higher overall frequency of Grade 3 or higher adverse events in the combination arm (65 vs. 59 percent), with close to half of these due to lab value abnormalities (mainly increased blood levels of liver enzymes and CPK). Common adverse events (occurring in more than 20 percent) observed at a