A EU panel has recommended regulatory approval of a tuberculosis drug that would become only the second major new antibiotic against the deadly disease in more than 40 years

Tuberculosis Drug Wins Backing of European Panel

Otsuka Pharmaceutical’s Deltyba Would Be Only Second New TB Drug Approved Since the 1970s

BETSY MCKAY

Nov. 22, 2013 9:34 p.m. ET

A European Union panel has recommended regulatory approval of a tuberculosis drug that would become only the second major new antibiotic against the deadly disease in more than 40 years. The European Medicines Agency’s Committee for Medicinal Products for Human Use said in a statement Friday that it had recommended conditional approval of delamanid, made by Otsuka Pharmaceutical Co. of Japan and to be sold under the trademark name Deltyba. The recommendation is considered a step toward approval; European regulators normally follow the committee’s advice. Otsuka said it expects a decision by the European Commission early next year.The same committee failed to give delamanid a thumbs up in July, arguing that the two-month period for which it had been studied in 481 drug-resistant patients wasn’t long enough to determine whether the drug would be effective in normal treatment courses of six months or more.

On Friday, the CHMP reversed that decision, recommending conditional approval of delamanid for treatment of drug-resistant pulmonary TB and requiring Otsuka to carry out additional studies on its long-term benefits and safety. The committee said that after studying the data again and consulting with infectious disease experts, it had determined that it was likely the drug would be effective over six months, as it had been in the two-month study.

If approved, delamanid would become only the second major new treatment to be developed since the 1970s for tuberculosis, a disease which infected an estimated 8.6 million people in 2012, killing 1.3 million of them. The first new drug, bedaquiline, made by a unit of Johnson & Johnson, JNJ +0.75% was approved by the U.S. Food and Drug Administration late last year and is being used in combination with other drugs to treat patients with multidrug-resistant tuberculosis, a form of the disease that infects an estimated 450,000 people a year and kills 170,000, though some local data suggest there are many more cases.

Delamanid also would be used in combination with other drugs on patients with MDR-TB. Its approval in Europe would be significant. Eastern Europe is a hot spot of MDR-TB, with some of the highest rates in the world.

Otsuka has been pursuing development of TB medications for more than 30 years; TB has been a priority area of research for the company’s chairman, Akihiko Otsuka, since he founded the company in 1971.

“Otsuka is very pleased with today’s CHMP opinion and that MDR-TB patients in Europe may soon have access to Deltyba,” an Otsuka spokesman said. He said the company would press ahead with ongoing studies of the drug and complete regulatory applications in countries with high burdens of MDR-TB.