TUBERCULOSIS: J&J tuberculosis drug gets FDA priority review
Sept. 5, 2012, 8:11 a.m. EDT
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.
After service in the British SAS Regiment the author became a physician and then an orthopaedic surgeon.
He has held professorial positions in Canada, Vietnam and the United States, practiced and taught orthopaedic surgery in three continents and in several wars.
He has extensive experience as an expert witness in court. Somewhere along the way, time was found to operate a four hundred acre mixed farm, a one hundred seat restaurant and to obtain a licence as a flying instructor.
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