The pharmaceutical company Teva has been attempting to develop a multiple sclerosis drug for years up to this point as a form of an heir to their previously released drug Copaxone that got discontinued. Unfortunately, the MS drug Laquinimod trials get delayed due to cardiovascular events in the patients receiving higher doses. Trials that involve lower dosage treatments will still go as planned.
The clinical trials conducted by Israel-based Teva Pharmaceuticals and Sweden’s Active Biotech, the creators of laquinimod, were done in four methods pertaining to four groups of patients. All of the subjects were suffering from multiple sclerosis, with each group receiving either a placebo or doses of laquinimod of 0.6 mg, 1.2 mg or 1.5 mg. The latter two dosages created an abnormal increase in cardiovascular risk in their clinical trial groups, urging their discontinuation, even though the events were non-fatal.
The group with a daily dosage of 1.2 mg of laquinimod was entering its third phase of clinical trials, the last phase before a drug gets approval from the FDA, when 7 patients started to suffer from nonfatal cardiovascular events, while, from the 1.5 mg dosage group, only one patient presented the same symptoms. The disparity between these two high dosage groups and the other two, with 0.6 mg doses or placebo pills, was found by the clinical trials’ data monitoring committee which in turn was forced to discontinue said trials.
Patients from the two canceled trials are advised by both Teva and Biotech to undergo follow-up checks in order to make sure that the risk of cardiovascular accidents has returned to normal levels. Share values for the two companies dropped immediately after this trial discontinuation was disclosed, with Teva dropping by 1.2% and Active Biotech by 33%, being the discoverers of the laquinimod small-molecule entity.
In order to counteract this unfortunate outcome, Teva has decided to include a Huntington disease study within its drug’s clinical trial program. The last remaining 0.6 mg dosage group will continue to progress, hopefully showing that the laquinimod drug is a viable solution when attempting to delay disability progression in Multiple Sclerosis.
If everything proceeds without any further incidents, the drug may get approval from the FDA in 2018. But even if it does, Teva’s new drug will have to face a tough competition in the form of the standard oral treatment with Tecfidera or Gilenya and in intravenous therapies with Lemtrada or Tysabri. The highly anticipated ocrelizumab from the Roche company is also expected to hit the markets next year, with analysts anticipating over $7 billion in annual revenue for said company.
Although the MS drug Laquinimod trials get delayed due to cardiovascular events, patients suffering from severe multiple sclerosis still hope that lower dosage treatments with this drug are deemed viable enough in order to attain FDA approval. By receiving oral therapy with laquinimod, MS patients will have another option of combating this terrible disease and even have the possibility of living a relatively normal life.