Johnson & Johnson's ($JNJ) Janssen has taken a step closer to gaining approval for the first new way of combating tuberculosis in decades. And an FDA advisory committee voted 18-0 in favor of efficacy of the experimental med, bedaquiline, for combating multidrug-resistant cases of the infection. Yet the panel was more mixed on the risks of the drug, voting 11-7 in support of safety data, as some experts question the effects of the treatment on the liver and heart, Reuters reported.
Based on promising results of midstage trials, Janssen set out in June to grab an accelerated approval for bedaquiline that would let the company begin marketing the therapy for cases of TB that thwart standard drugs while a Phase III study confirms earlier findings. As Reuters reports, the FDA often follows the advice of its advisory committees, making the positive votes yesterday good news for J&J as it attempts to market the first new drug with a new line of attack against TB in four decades.
Drug-resistant infections present one of the biggest global health threats, and the FDA has set up a task force to energize development of new antibiotics that combat tough-to-treat bugs. The economics of antibiotics development carry challenges not seen with meds taken on an ongoing basis for conditions such as depression or high cholesterol. Major drugmakers have been largely absent from new antibiotics development, yet J&J and others such as AstraZeneca ($AZN) and GlaxoSmithKline ($GSK) have made modest moves to pick up some of the slack.
Johnson & Johnson isn't expected to make blockbuster profits from its new TB drug in the U.S., where Dow Jones Newswires reports there are only about 100 cases of multidrug-resistant infection annually. And numbers of such cases are much higher in poorer countries. In a note to investors this morning, Cowen & Co. projected peak sales of $400 million to $500 million for bedaquiline if it can gain wide adoption, in both the developed world and in emerging markets where most cases of TB crop up.