Teva Pharmaceutical Industries has been boosted by the news that regulators in the USA have approved a longer-acting version of its multiple sclerosis blockbuster Copaxone.
The US Food and Drug Administration has given the green light to the Israeli company’s supplemental New Drug Application for three-times-a-week Copaxone (glatiramer acetate). The new formulation will allow for a less frequent dosing regimen compared with the daily subcutaneous injection which was approved in 1996 but is coming off-patent.
Teva quoted Omar Khan of the Wayne State University School of Medicine in Detroit, as saying that the availability of three-times-a-week Copaxone "is a significant advancement for patients as they now have the option of effective and safe treatment…while reducing the number of injections by 60%". He added that US patients "can now benefit from an improved dosing regimen without compromising the known benefits" of the drug.
Teva will now look to switch a significant number patients from daily Copaxone ahead of the launch of generic versions of the latter in the coming months. The treatment is already fighting to keep market share from the spate of oral MS pills that have hit the US market, namely Novartis' Gilenya (fingolimod), Biogen Idec’s Tecfidera (dimethyl fumarate) and Sanofi’s Aubagio (teriflunomide).