J&J preps case for quick FDA approval of new TB drug

Johnson & Johnson ($JNJ) has set out to navigate its way through an important stage of its campaign to gain an accelerated approval for a new therapy for drug-resistant tuberculosis. Later in the week a panel of outside FDA experts will give J&J's bedaquiline team a thorough examination to see whether the company warrants a preliminary approval based on Phase II data. And today the agency released its carefully neutral view of the data on safety and efficacy.

In what could prove significant for other developers, J&J wants to use data on a surrogate endpoint: time to sputum culture conversion up to week 24 evaluated in two separate stages of a Phase II study. The agency review confirms that the drug proved more effective in the clinical study than a placebo. The Wall Street Journal also notes that the FDA review concludes that the drug is "safe and well tolerated."

Cases of drug-resistant TB have alarmed health officials and earned acknowledgement from the FDA reviewers, who noted that the distressing trend "threatens to erode the progress made in the world-wide control of tuberculosis." That concern is likely to help J&J in its quest to gain an early approval while Phase III is still underway. And it should also help other developers understand how the FDA will view similar marketing applications based on surrogate endpoints.

The FDA's anti-infective drugs advisory committee meets on Wednesday.

- here's the FDA review (PDF)
- read the report from The Wall Street Journal (sub. req.)

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.