Pfizer, Novartis and Celgene among late-stage psoriasis trial advances
pharmafile | March 23, 2015 | News story | Sales and Marketing | Celgene, Cosentyx, Enbrel, FDA, Novartis, Pfizer, otezla, psoriasis, tofacitinib
Pfizer bosses say they are confident of a positive FDA application for tofacitinib after announcing positive Phase III study results.
The US company has made a supplemental new drug application for tofacitinib 10 mg and 5 mg tablets, for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The FDA has said it expects to have made a decision by October 2015.
The results of two studies found people with psoriasis who were treated with the two tofacitinib doses showed more improvement in their skin symptoms compared to people on a placebo treatment.
After 16 weeks more people treated with tofacitinib met the primary efficacy endpoints; two commonly-used measures of successful psoriasis treatment: achieving a Physician’s Global Assessment response of ‘clear’ or ‘almost clear’, and achieving at least a 75% reduction in Psoriasis Area and Severity Index. Rates of serious adverse events and infections were similar between active treatment and placebo arms.
”We are excited about the data as it adds to the body of evidence for oral tofacitinib in patients with moderate to severe plaque psoriasis. Results from these studies supported Pfizer’s recent FDA filing seeking a psoriasis indication in the United States,” says Steve Romano, senior vice president and head of global medicines development for the Pfizer global innovative pharmaceutical business.
“The robust data seen in the studies provide important information on the profile of oral tofacitinib for moderate to severe psoriasis, and underscore that if approved, tofacitinib may offer a clinically meaningful option in oral therapy as the first potential treatment in a new class of medicines for this chronic condition,” says Dr Kim Papp, from Probity Medical Research and the lead investigator.
At the same conference Celgene presented results of a post-hoc analysis that found no statistically significant difference between Otezla (apremilast) and Pfizer’s Enbrel (etanercept) – although the study was not designed to compare the two drugs. A second study found positive results after two years of treatment with Otezla in people with difficult-to-treat psoriasis.
And Novartis presented positive findings from a two-year extension of two earlier Phase III studies of Cosentyx (secukinumab), the only IL-17A inhibitor approved in Europe and the US for people with moderate-to-severe plaque psoriasis.
After two years, around 90% of people who had treatment with Cosentyx sustained their improvement in symptoms. And 70% of patients who initially received placebo who were switched to Cosentyx saw an improvement in their symptoms within 12 weeks of starting treatment.
Lilian Anekwe
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