Teva, AB Science and PTC Therapeutics all face rejections for new medicines in EU following the latest round of regulator opinions.
The three firms join Novartis in receiving negative recommendations from the Committee for Medicinal Products for Human Use (CHMP), which advises the European Medicines Agency (EMA) on marketing approvals for new drugs.
As reported yesterday Novartis was hit with a negative recommendation for heart failure candidate serelaxin, while the other opinions cover Teva’s multiple sclerosis (MS) candidate laquinimod, AB Science’s pancreatic cancer candidate masitinib and PTC’s ataluren for the treatment of Duchenne muscular dystrophy.
Teva’s laquinimod, which was filed with the brand name Nerventra, is one of several new oral MS drugs that have been tipped to make big sales as simpler to administer alternatives to current treatments.
However, the CHMP said it has concerns about the safety of the drug, noting that, in animal studies, laquinimod was associated with a higher occurrence of cancer after long-term exposure.
The regulator’s statement said: “[A] similar long-term cancer risk could not be excluded in humans, especially when considering that the way the medicine works in the body is unclear.”
Other risks include the effect of the drug on unborn babies in pregnant women, with these issues leading the CHMP to determine the benefits of laquinimod in MS patients did not outweigh its risks.
In Teva’s response to the decision, the Israeli company said it and partner Active Biotech were committed to the development of laquinimod as a treatment for MS and will request a re-examination of the CHMP opinion.
The drug is also in development for Crohn’s disease and further studies are planned in other neurodegenerative conditions, including Huntington’s disease.
Negative opinions for AB Science and PTC
The CHMP also issued a negative recommendation for AB Science’s oncology candidate masitinib, which was under review under the brand name Masiviera for use in the treatment of advanced inoperable pancreatic cancer.
The refusal statement said the results of the main study provide by AB Science did not show effectiveness in the overall group of patients with advanced or metastatic pancreatic cancer
The CHMP did acknowledge that a subgroup of patients with generic mutations were able to benefit from the drug but the study was not designed in a way to show benefits in smaller groups, meaning further trials were needed.
There were also problems with the toxicity of masitinib and potential impurities due to the quality of the product.
The final negative option was for PTC’s ataluren, under review as a treatment for the genetic muscle weakness condition Duchenne muscular dystrophy.
Concerns about ataluren – reviewed under the brand name Translarna – included the failure of the main study submitted by PTC to demonstrate that the drug was better than placebo in improving the distance a patient can walk in six minutes.