fiercepharmaMarch 03, 2019
Tag: Johnson & Johnson , TREMFYA , at-home injector nod
Johnson & Johnson’s Tremfya put a key rival on defense late last year with head-to-head data, and it’s keeping the heat on its competitors.
The New Jersey drugmaker’s Janssen unit grabbed an FDA approval Thursday for One-Press, a single-dose injector that adults with plaque psoriasis can use to administer Tremfya at home. The company is hoping the new device's features will help it contend with nemeses in the ultracompetitive psoriasis arena, including Novartis’ Cosentyx and Eli Lilly’s Taltz.
Those features allow patients to control the rate and pressure of their injection, the company said. They also make it easy to use, with a click indicating that dosing is complete; nearly 99% of trial patients reported nailing the injection on the first try. Responders to a questionnaire from the pharma rated their mean satisfaction with the product at 9.18 out of 10 and its ease of use at 9.24 out of 10.
But perhaps most importantly, the device will up Tremfya’s convenience factor. The new option will allow patients to avoid going to a clinic to receive the drug, provided their doctors approve. Tremfya is injected every 8 weeks after two starter doses four weeks apart.
Johnson & Johnson is pushing hard to gain share for Tremfya, and despite entering the market behind a slew of rivals, the company still sees "a very compelling value proposition" in the disease area, Jennifer Taubert, J&J’s executive vice president and worldwide pharma chairman, said at January’s J.P. Morgan Healthcare Conference.
In addition to One-Press, it’s hoping new head-to-head data against current leader Cosentyx can give Tremfya a boost, too. December results from J&J’s Eclipse study showed that at the 48-week mark, 84.5% of Tremfya patients achieved a score of 90 on the Psoriasis Area Severity Index, a commonly used metric for measuring response to psoriasis drugs—and only 70% of patients taking the Novartis blockbuster hit that mark.
Novartis executives, for their part, have shrugged off the threat, with Sam Khalil, Ph.D., Novartis’ head of worldwide medical affairs for immunology, hepatology and dermatology, predicting at the time that "the Eclipse data will have limited clinical relevance."
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