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The European Commission has approved Novartis for the monoclonal antibody Erenumab (Aimovig ® ). The product is indicated for the prophylaxis of migraine in adult patients with migraine for at least four days per month. It is the first officially approved drug for the prevention of migraine attacks. Other drugs have been used off label until now. Prescribe the new drug only to doctors who have experience with the diagnosis and treatment of migraine.
The solution for injection with erenumab 70 mg comes as a pre-filled syringe and pre-filled pen on the market. Patients can self-inject the agent subcutaneously into the thigh or abdomen every four weeks. If necessary, a monthly dose of 140 mg of erenumab is also possible
Erenumab specifically blocks the receptor for the calcitonin gene-related peptide (CGRP). CGRP is a neuropeptide that presumably transmits pain signals in migraine and vasodilator attacks. At the start of an attack, CGRP levels are increased and brought back to normal levels when the attack is over. Infusion of CGRP in the subject triggers migraine headaches.
In the study program with approximately 2600 participants, the majority of patients who responded to the therapy had a protective effect against migraine attacks within three months. Patients who do not respond after three months of treatment should be considered as discontinuing treatment, summarizes the summary of the drug. It is planned to evaluate at regular intervals whether the treatment continues.
In patients suffering from chronic migraine (18 days per month on average) treated with other drugs without success, the number of days of migraine decreases depending on the dose and pretreatment about 2.5 to 4 ,3 days. 34.7% of erenumab 70 mg achieved a reduction of at least 50% compared to 17.3% with placebo. Also in patients with episodic migraine (an average of eight days per month) showed a protective effect. They suffered erenumab 140 mg for 2.5 days and erenumab 70 mg for 2.0 days less migraine than patients in the placebo group. Constipation, itching, muscle spasms, and injection site reactions have often manifested as side effects. The most common side effects are viral infections of the upper respiratory tract, sinusitis, influenza and back pain.
Novartis plans to launch the drug later this year. The pharmaceutical company is planning innovative payment models, for example, payers should only pay for patients who respond to treatment. (ie)
31.07.2018 l PZ
Photo: Novartis
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