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Novartis’ Phase 3 migraine data could revolutionise treatment

Published on 30/11/17 at 09:38am

Descriptions of treatments as ‘revolutionary’ or ‘ground-breaking’ are ten a penny in the pharmaceutical industry, very rarely do such treatments actually deliver on that promise. For Novartis, and its partner, Amgen, it may be time to get excited about its treatment for migraines, after it published strong Phase 3 data.

The drug is erenumab and the trial, consisting of 955 patients, was able to show that 50% of those receiving the strongest dose of the treatment had their number of migraine days reduced by at least half. This compared strongly to treatment with placebo, which managed only 26% of patients achieving the same reduction.

In a major bonus to the companies involved, the treatment was also shown to be safe, in the short-term; 90% of patients completed the study, with only 2.2% of those receiving erenumab discontinuing treatment due to adverse reactions to the drug.

As yet, long-term safety data has not been accrued on the treatment. However, the treatment was found to begin working quickly – meaning it could be prescribed and efficacy could be evaluated after initial treatment, allowing for rapid discontinuation if the patient is not receptive.

This means that for those suffering from migraines they will have a drug that is specifically designed to treatment migraines – unlike current treatments, which are often repurposed older drugs, such as epilepsy treatments and Botox.

“The results of the Strive study add to the evidence for the significant, consistent benefits of erenumab seen across the spectrum of chronic and episodic migraine, including patients who failed on previous preventive treatments,” said soon-to-be-CEO of Novartis, Vas Narasimhan. “People with migraine are missing out due to this debilitating neurological disease and are in need of safe, tolerable and effective preventive treatments. We are committed to bringing this much-needed treatment option to patients as soon as possible.”

Erenumab is a fully human monoclonal antibody that works by specifically blocking the CGRP receptor, with the CGRP chemical having been shown to be closely related to pain and sensitivity to light and sound. This target is also being worked on by Teva, Eli Lilly and Alder Biopharmaceuticals, and is a market that could be worth $8.75 billion.

The race is on to have treatments approved, with Novartis/Amgen and Teva already having filed to the FDA for their treatments.

The major hurdle to reach patients, as is often the case, will be where the price is set on the treatment and how willing national payers will be to stump up for the treatment. Due to the complexity of manufacture, the cost of the drug is likely to be relatively high and with a potential 500,000 eligible patients in the UK alone, it is reasonable to predict a fair amount of negotiations occurring between NICE and the two partners to determine a cost-effective price.

Ben Hargreaves

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