NEW YORK, Dec 3 (Reuters) - Teva Pharmaceutical Industries Ltd’s TEVA.O Copaxone reduced the risk of patients developing multiple sclerosis after they showed an initial sign of the central nervous system disorder, the company said on Monday.
Interim results of a 481-patient study showed treatment with Copaxone cut the risk of developing clinically definite multiple sclerosis by 44 percent compared with a placebo.
Patients in the study had suffered one attack, such as extended numbness, dizziness or blurred vision and had a brain scan image consistent with multiple sclerosis.
Clinically definite multiple sclerosis is when a patient suffers a second such attack.
Of patients in the study that got that clinically defining second attack, those on Copaxone took more than twice as long — 722 days versus 336 days — before getting the attack as those on placebo.
After seeing the interim results of the clinical trial, an independent committee monitoring the study recommended the placebo arm of the trial be stopped and that all placebo patients be given the opportunity to receive Copaxone, Teva said.
Teva said it plans to seek approval from regulators for Copaxone as a treatment for patients with a first clinical event suggestive of multiple sclerosis.
A Teva official said winning such approvals could help remove reimbursement obstacles, particularly outside the United States, for patients prescribed Copaxone for this use.
Patients in the study were to receive either an injection of Copaxone or a placebo for up to 36 months, unless they suffered a second attack.
In the interim analysis, the proportion of patients developing clinically definite multiple sclerosis was 43 percent in the placebo group compared with 25 percent in the Copaxone group, Teva said.
Teva shares were up 54 cents, or 1.2 percent, at $45.17 in afternoon trading on the Nasdaq. (Reporting by Lewis Krauskopf; Editing by Andre Grenon)