What is Wakix - Pitolisant used for and what is it used for?
Rasagiline Mylan is a medicine indicated for the treatment of adult patients with Parkinson's disease (a progressive brain disease that causes tremor, slowness of movement and muscle stiffness).
Rasagiline Mylan can be used alone or as an adjunctive therapy to levodopa (another medicine used in Parkinson's disease), in patients with fluctuations in the control of the disease. Fluctuations occur when the effects of the medicine run out and symptoms recur before the next dose. They are due to a reduction in the effect of levodopa, when the patient suddenly goes from "on" phases in which he is able to move, to "off" phases in which he has difficulty in movement.
Rasagiline Mylan is a "generic medicine". This means that Rasagiline Mylan is similar to a 'reference medicine' already authorized in the European Union (EU) called Azilect. For more information on generic medicines, see the questions and answers by clicking here.
Rasagiline Mylan contains the active ingredient rasagiline.
How is Wakix - Pitolisant used?
Rasagiline Mylan is available in tablet form (1 mg). The standard dose is one tablet once a day.
The medicine can only be obtained with a prescription.
How does Wakix - Pitolisant work?
The active substance in Rasagiline Mylan, rasagiline, is a monoamine oxidase B inhibitor. It blocks the enzyme monoamine oxidase type B which degrades a substance called dopamine in the brain. Dopamine is important for movement control and coordination. In patients with Parkinson's disease there is a loss of dopamine-producing cells and, therefore, a reduction in the amount of this substance present in the brain. Patients therefore lose the ability to control their movements reliably. Rasagiline Mylan reduces the symptoms of Parkinson's disease, such as stiffness and slowness in movement, increasing dopamine levels in areas of the brain that control movement and coordination.
What benefit has Wakix - Pitolisant shown during the studies?
Because Rasagiline Mylan is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Azilect. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body
What is the risk associated with Wakix - Pitolisant?
Because Rasagiline Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Wakix - Pitolisant been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rasagiline Mylan has been shown to have comparable quality and to be bioequivalent to Azilect. Therefore, the CHMP considered that, as in the case of Azilect, the benefits outweigh the identified risks and recommended to approve the use of Rasagiline Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Wakix - Pitolisant?
A risk management plan has been developed to ensure that Rasagiline Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Wakix - Pitolisant
For the full EPAR version of Rasagiline Mylan, consult the Agency website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Rasagiline Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website.
