J&J tuberculosis drug gets FDA priority review

By Tess Stynes

Johnson & Johnson's JNJ -0.07% Janssen unit received the U.S. Food and Drug Administration's priority review status for its pulmonary, multidrug-resistant tuberculosis treatment that is used in combination with other therapies.

The FDA is expected to decide on J&J's new drug application for bedaquiline early next year. The health-care conglomerate's new drug application was filed in late June.

"If approved, bedaquiline would offer the first in a new class of anti-tuberculosis drugs for patients suffering from this serious and deadly disease," said Wim Parys, head of Janssen's infectious diseases therapeutic area.

Priority review status is granted for medicines that offer major advances or provide a treatment option where there currently isn't an adequate therapy.

J&J and other pharmaceutical companies have been trying to fill their drug pipelines as the industry faces a steep loss of patents. While J&J has introduced some promising new drugs recently, sales have been pressured by the loss of patent protection for older drugs, including attention deficit/hyperactivity disorder treatment Concerta.

Shares closed Tuesday at $67.26 and were inactive premarket. The stock is up 2.6% this year, trailing the broader market.