Teva Provides Update on Glatiramer Acetate 40mg for Amyotrophic Lateral Sclerosis (ALS)
GA 40 mg was safe and well tolerated in ALS patients; however, study did not meet primary end point
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced final results from the global phase II GoALS trial. The study was designed to assess the safety, tolerability and efficacy of glatiramer acetate (GA) 40 mg, given once daily as a subcutaneous injection, in reducing disease-related functional deterioration in Amyotrophic Lateral Sclerosis (ALS) patients. Results show that GA 40mg was safe and well-tolerated in ALS patients; however, the study's primary and secondary endpoints were not met.
â€œDespite our hopes and desires, similar to other drug candidates for the treatment of ALS, GA 40 mg did not prove beneficial for ALS patients but was shown to be safe and well tolerated," said Professor Vincent Meininger from Hopital de la Salpetriere, Paris, France, and principal investigator of the study, â€œThe academic community caring for ALS patients, is very pleased with Teva's commitment to continue developing innovative treatment options such as Talampanel for such a devastating disease".
About the study
The multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase II study was conducted in 13 centers located in Israel, Belgium, France, Germany, Italy and the United Kingdom and included 366 patients with ALS. Patients received either GA 40 mg or placebo as a subcutaneous injection and continued treatment for 52 weeks. The primary outcome measure was change in ALS ALSFRS-R score. The secondary outcome measure was increased survival. The study results show that GA 40mg is not effective in the treatment of ALS; however, the drug was safe and very well tolerated.
About Glatiramer Acetate
Glatiramer acetate is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (RRMS).
About Amyotrophic Lateral Sclerosis (ALS)
ALS, also known as "Lou Gehrig's disease", is a degenerative motor neuron disease that leads to paralysis and ultimately, to death, usually within 3-5 years from disease onset. The cause of death is most often due to respiratory failure. Progressive symptoms of the disease include muscle weakness in limbs, muscle twitching (fasciculation) and cramping, speech impediments, difficulty swallowing and respiratory impairment. Over 10,000 people in the U.S. and Europe are diagnosed with ALS each year. It is estimated that at least 50,000 people worldwide have the disease at any given time.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Tevaâ€™s sales are in North America and Europe.
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