FDA OKs Biologic Guselkumab (Tremfya) for Plaque Psoriasis

Megan Brooks

Disclosures

July 14, 2017

The US Food and Drug Administration (FDA) has approved guselkumab (Tremfya, Janssen Biotech) for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, the company has announced.

Guselkumab is the first and only approved biologic agent that selectively blocks interleukin-23 (IL-23), which plays a key role in plaque psoriasis, the company said in a news release. 

The monoclonal antibody is given as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at week 0 and week 4.

Guselkumab represents a "significant milestone in the treatment of moderate to severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23-specific therapy at week 16 and up to week 48," study investigator Andrew Blauvelt, MD, president, Oregon Medical Research Center, Portland, said in the news release.

"We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease, which is another reason why today's approval of [guselkumab] is exciting, both as a researcher and a practicing dermatologist," he added.

The FDA cleared guselkumab based on results from a clinical development program that included more than 2000 patients in three phase 3 studies.

At 16 weeks, at least 7 of 10 patients treated with guselkumab achieved at least 90% clearer skin (Psoriasis Area and Severity Index [PASI 90]) and more than 80% demonstrated cleared or almost cleared skin. Patients who achieved PASI 90 at week 28 maintained that response at week 48, the company said.

Guselkumab also improved psoriasis involving the scalp and symptoms of plaque psoriasis, including itch, pain, stinging, burning, and skin tightness, at week 16.

Guselkumab demonstrated superior results in skin clearance compared with adalimumab (Humira, AbbVie) in head-to-head analyses at weeks 16, 24, and 48, the company said.  Guselkumab also demonstrated effectiveness in patients who had an inadequate response to ustekinumab (Stelara, Janssen Biotech).

"The approval of new and effective treatment options is always welcome news for the plaque psoriasis patient community, as not all patients respond similarly to currently available treatments," said Michael Siegel, PhD, vice president of research programs for the National Psoriasis Foundation. "For the more than one million Americans living with moderate to severe plaque psoriasis, the approval of [guselkumab] is a meaningful addition and offers physicians and patients an effective new, first-in-class therapy that selectively inhibits IL-23."

Janssen said it will work closely with payers, providers, and pharmacy benefit managers to ensure guselkumab is broadly accessible and affordable for patients and that the cost for payers is competitive with currently available biologic therapies for psoriasis.

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