Questions & Answers
Update of 21 February 2014:
The applicant for Nerventra has requested a re-examination of the CHMP’s January 2014 opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation.
On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
The company that applied for authorisation is Teva Pharma GmbH. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
- What is Nerventra?
Nerventra is a medicine that contains the active substance laquinimod. It was to be available as capsules.
- What was Nerventra expected to be used for?
Nerventra was expected to be used to treat multiple sclerosis (MS), 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 MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
- How is Nerventra expected to work?
The exact way Nerventra works is not known, but it is believed to act as a modulator of 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 MS.
- What did the company present to support its application?
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 MS. One of the studies involving 1,106 patients compared Nerventra with placebo (a dummy treatment), while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat MS, 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’).
- What were the CHMP’s main concerns that led to the refusal?
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 any 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.
Although the medicine was shown to slow the worsening of disability, the medicine’s effect on relapses was modest. The CHMP was of the view that the benefits of Nerventra in patients with relapsing remitting MS do not outweigh the potential risks and recommended that it be refused marketing authorisation.
- What consequences does this refusal have for patients in clinical trials?
The company informed the CHMP that there are a number of ongoing and planned clinical trials with Nerventra in patients with multiple sclerosis and other conditions. The CHMP opinion has no consequences on these trials for the time being. If you are taking part in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
|Name||Language||First published||Last updated|
|Questions and answers on refusal of the marketing authorisation for Nerventra||(English only)||24/01/2014||21/02/2014|
|INN or common name|
|Therapeutic area||Multiple Sclerosis|
|Date opinion adopted||23/01/2014|
Teva Pharma GmbH
|Application type||Initial authorisation|