Novartis’ mAb becomes first for migraines in EU

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Slphotography)
(Image: Getty/Slphotography)

Related tags: Novartis, Amgen, Aimovig, Migraine

The European Commission has given its approval for Novartis’ Aimovig, the treatment designed specifically for patients with migraines.

The monoclonal antibody (mAb) will be made available for adult patients who experience at least four migraine days per month.

Aimovig (erenumab) is the first treatment specifically designed to treat migraines to receive approval. It works by blocking the calcitonin gene-related peptide (CGRP) receptor, which has been linked to pain signals associated with migraines.

The treatment is delivered every four weeks via an auto-injector pen, which can be self-administered or injected by a trained individual. In recently published results for two trials into the treatment of patients with chronic migraines (classified as having 15 or more migraine days per month), Aimovig showed​ an average monthly reduction of migraine days of 10.5 and 8.5 days.

A spokesperson for Novartis told us that it is now working with the migraine community to improve care for people living with the disease. They further explained that this involved working with patient advocacy groups to support their work.

Forming a pricing plan

Novartis is commercialising Aimovig in the US alongside its partner, Amgen. So far, the companies have taken an aggressive tact to marketing the product – by offering free monthly trials of the product​.

The product has been approved in the US since May​ but in Q2 financials, Amgen revealed that the product had yet to make a significant impact​.

When asked about Novartis’ pricing plan for Europe, the spokesperson for Novartis commented: “Aimovig will be priced responsibly in accordance with our company values. Aimovig’s price in each market will be determined by local factors, including unmet medical needs; clinical and quality of life measures; the value of the product in relation to standards of care, and the product’s ability to mitigate the economic, healthcare and social burden of the disease.”

Both Amgen and Novartis need uptake of Aimovig to be quick in both the US and European markets, as there are several rivals waiting in the wings to bring their own CGRP inhibitors to market. One such competitor is Teva, which may be delayed in its efforts to enter the race, after its partner’s facility received a warning letter​ for a site producing its own CGRP inhibitor mAb.

Related topics: Markets & Regulations

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