Migraine headache in adults

European Medicines Agency (EMA) strengthens measures to avoid use of valproate medicines in pregnancy

In March 2018, the EMA announced stronger measures aimed at avoiding the exposure of babies to valproate medicines in the womb. Under the new restrictions, valproate medicines are contraindicated for migraine prophylaxis during pregnancy due to the high risk of congenital malformations and developmental problems in the child.

In addition, valproate medicines must not be used in female patients of childbearing potential unless there is a pregnancy prevention programme in place that includes the following:

• An assessment of the patient’s potential for becoming pregnant

• Pregnancy tests before starting (and during) treatment as needed

• Counselling about the risks of valproate treatment and the need for effective contraception throughout treatment

• A review of ongoing treatment by a specialist, at least annually

• A risk acknowledgement form that patients and prescribers can go through at each such annual review to confirm that appropriate advice has been given and understood.

The EMA said the new measures were put in place because of evidence suggesting that information on the risks of valproate use in pregnancy was still not getting through to women, despite earlier steps aimed at ensuring this.

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Erenumab approved in the EU for the prevention of migraine

Erenumab, a novel treatment for migraine prevention, has been approved by the European Medicines Agency (EMA) for the prophylaxis of migraine in adults who have at least 4 migraine days per month. Erenumab is a first-in-class fully human monoclonal antibody that works by inhibiting the calcitonin gene‑related peptide (CGRP) receptors. The CGRP is believed to play a causal role in the pathophysiology of migraine. Erenumab is administered as a once-monthly subcutaneous injection. According to the EMA, the benefit of erenumab treatment is its ability to reduce the number of monthly migraine days. In two trials involving 667 patients with chronic migraine and 955 with episodic migraine, patients with chronic migraine showed a reduction of 2.5 monthly migraine days on average compared to placebo after three months of treatment. For patients with episodic migraine the reduction was either 1.3 or 1.8 days, depending on the dose taken. The most common side effects were injection site reactions, constipation, muscle spasms and pruritus.

The Food and Drug Administration in the US approved erenumab in May 2018 for the preventive treatment of migraine in adults.

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