Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
Nerventra is a medicine that contains the active substance Laquinimod. It was to be available as capsules.
Nerventra was expected to be used to treat multiple sclerosis, a disease in which the immune system malfunctions, causing inflammation that destroys the protective sheath around the nerves in the brain and spinal cord.
Nerventra was to be used in the type of multiple sclerosis known as relapsing-remitting multiple sclerosis, when the patient has relapses followed by periods of recovery ( remissions ).
The exact way Nerventra works is not known, but it is believed to have a modulator effect on the immune system. By modulating the immune system it is expected to help control the inflammation and the damage to nerves, thus helping to reduce symptoms and the worsening of disability in patients with multiple sclerosis.
The effects of Nerventra were first tested in experimental models before being studied in humans. The company also provided results of two main studies in patients with relapsing-remitting multiple sclerosis. One of the studies involving 1,106 patients compared Nerventra with placebo, while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat multiple sclerosis, Interferon-beta 1a.
Both studies lasted two years and the main measure of effectiveness was based on the reduction in the number of relapses per patient per year ( what is known as the annualised relapse rate ).
At the time of the initial recommendation, the CHMP had concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to the medicine and noted that 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.
There was also a possible risk ( again from animal studies ) of effects on the unborn baby when the medicine is taken by pregnant women.
The CHMP noted that the risk could not be excluded with current data and that animal studies suggest that some of the harmful effects may be delayed and only seen later on in the child’s life.
In addition, the Committee was not convinced about the effectiveness of the company’s proposed measures to prevent pregnancies in women who would take the medicine.
During the re-examination, the CHMP considered advice from an expert group in neurology. The expert group advised that the risks seen in animal studies could have been acceptable if a clear benefit was seen in clinical studies, although a strict pregnancy prevention scheme would have been required.
The CHMP noted that the effect of the medicine in preventing relapses was modest, and though its effect in slowing the worsening of disability was encouraging it still needed to be confirmed.
Therefore the Committee concluded that the benefits of Nerventra at the dose studied were not sufficient to outweigh the potential risks in patients with relapsing remitting multiple sclerosis and maintained its recommendation that the medicine be refused marketing authorisation. ( Xagena )
Source: EMA ( European Medicines Agency ), 2014
XagenaMedicine_2014
