NEW YORK, Dec 19 (Reuters) - Johnson & Johnson said on Friday U.S. regulators have held off making a decision on the company’s experimental psoriasis drug ustekinumab until they receive certain risk-mitigation information, but will not require new studies on the promising drug.
J&J (JNJ.N), whose shares rose 1 percent, said the U.S. Food and Drug Administration issued a Complete Response letter for the drug, a type of document sometimes issued when the agency has not had time to adequately review a medicine.
Such letters can also be issued when the FDA needs information of some sort to complete its review. Companies are not required, however, to divulge detailed contents of the letters.
“The Complete Response letter requests additional information, including a proposal ... for a risk evaluation and mitigation strategy” to ensure the drug’s benefits outweigh its risks, J&J said in a release.
J&J said the letter requests a medication guide and communication plan as part of the requested risk-mitigation documentation. The diversified healthcare company said it plans to respond to the FDA next month and remains focused on bringing the drug — deemed a potential blockbuster — to market.
J&J shares were up 1.2 percent at $59.70 in morning trading on the New York Stock Exchange, amid a 1.6 percent gain for the American Stock Exchange Pharmaceutical Index .DRG of large drugmakers.
Psoriasis, a condition in which itchy red plaques accumulate on the surface of the skin, is caused by an overproduction of skin cells. It affects an estimated 7.5 million patients in the United States, J&J said.
Ustekinumab, a monoclonal antibody which was highly effective in treating psoriasis in clinical trials, is given by infrequent injections and works by taming two immune system proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23) that are linked to inflammation.
It was well tolerated in two large trials, with generally mild side effects that did not require adjustments in the medicine.
By contrast, current treatments — including Wyeth’s WYE.N leading injectable Enbrel, Abbott Laboratories’ (ABT.N) injectable Humira and J&J’s older Remicade medicine that is given by intravenous infusion — can increase risk of infection and reactivate tuberculosis. (Reporting by Ransdell Pierson, editing by Dave Zimmerman)