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Lilly's Reyvow becomes first FDA-approved 5-HT1F receptor agonist for acute migraine

Eli Lilly has announced that the FDA has given the green light to Reyvow (lasmiditan) in the acute treatment of migraine, with or without aura, in adult patients. According to the regulator, this marks the first and only FDA approval of a serotonin (5-HT)1F receptor agonists in this treatment area.

Supporting the approval were data from two Phase 3 studies, both of which met their primary endpoints of pain freedom and freedom from most bothersome symptoms – including nausea, light sensitivity and sound sensitivity – two hours following administration, compared to placebo.

NICE shoots down Novartis' migraine drug Aimovig outside of Scotland

NICE has announced its decision to reject Novartis’ drug Aimovig (erenumab) for use on the NHS in England and Wales for the prevention of chronic and episodic migraine in adult patients who experience at least four episodes of migraine a month.

NICE said that Novartis had proposed that the drug be offered to patients who have not seen an adequate response from at least three other treatments for episodic or chronic migraine, but an independent committee voiced concerns over the aptitude of the clinical data provided to support the application.

Lundbeck acquires Alder in $2bn migraine treatment move

Lundbeck HQ

Lundbeck is to buy Alder Biopharmaceuticals for $2 billion enhancing its leading portfolio of brain disease therapies through the acquisition of eptinezumab, an investigational monoclonal antibody for migraine prevention.

Under the terms of the agreement Lundbeck will initiate a tender offer for all outstanding shares of Alder, whereby Alder stockholders will be offered an upfront payment for USD 18.00 per share in cash alongside one non-tradeable Contingent Value Right of USD 2.00 per share.

4.5-year data confirms long-term efficacy of Novartis' Aimovig in episodic migraine

Novartis has lifted the curtain on interim data from the 4.5-year mark of a five-year open-label treatment period (OLTP) investigating the sustained efficacy of Aimovig (erenumab) in the treatment of episodic migraine.

At the beginning of the OLTP, all patients began treatment with 70mg Aimovig, and this was increased to 140mg in the 250 patients that continued treatment for more than approximately two years. Of these 250 patients, 221 (88%) continued receiving treatment for the duration of the OLTP or remained on 140mg after 4.5 years.

Pfizer recall two batches of migraine drug Relpax

Pfizer has recalled two lots of its migraine drug Relpax over concerns about microbiological contamination.

In a statement on the FDA website, Pfizer said: “Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life- threatening infections.”

However the firm said the risk of infection was low for the general population. The risk may be higher for those with compromised immune systems, cystic fibrosis and chronic granulomatous disease.

Lilly's Emgality smashes all Phase 3 endpoints in migraine sub-population

New Phase 3 data have been revealed on Eli Lilly’s Emgality (galcanezumab-gnlm), detailing its success in meeting all of its primary and secondary endpoints as a preventive treatment for chronic and episodic migraine in patients who have previously failed to control their condition with other migraine medications.

Specifically, the indicated patient population refers to those who have found inadequate relief with two to four different standard-of-care migraine preventive medication categories, either because of efficacy or safety and tolerability reasons.

Biohaven's CGPR antagonist migraine treatment beats placebo in Phase 3 trial

Connecticut-based firm Biohaven has said its migraine drug rimegepant showed superiority over placebo in a Phase 3 clinical trial.

The calcitonin gene-related peptide (CGRP) receptor antagonist was successful in relieving pain in patients with migraine in a Phase 3 trial, the results of which are published in the New England Journal of Medicine (NEJM).

Eli Lilly's Emgality approved in the US for episodic cluster headache

Eli Lilly’s Emgality (galcanezumab-gnlm) self-administered injection solution has secured approval in the US for the treatment of episodic cluster headache, it has emerged.

The therapy showed its efficacy in the approved indication in a trial of 106 patients. Participants were measured for their average number of cluster headaches per week for three weeks to establish a baseline; it was found that Lilly’s drug reduced the average number of attacks by 8.7 on average from baseline, compared to a reduction of 5.2 with placebo.

FDA approves Theranica's smartphone-controlled electroceutical device for migraine

Image Credit: Theranica Bioelectronics

Biomedical tech company Theranica has secured FDA approval for Nerivio Migra, its wearable, smartphone-controlled electroceutical device, for the acute treatment of migraine in patients with or without aura who do not have chronic migraine.

Placed on the upper arm, Nerivio Migra creates a Conditioned Pain Modulation (CPM) response through electronic pulses, promising “significant relief” of pain or migraine symptoms without the side-effects of drug treatment – a key concern when a study of 2,444 people recently showed that around two-thirds delayed or avoided taking medications bec

Top Ten most popular articles on this week!

This week was a particularly bad one for the NHS after it was revealed thousands of EU nurses were leaving while the number of GPs had gone into decline for the first time in 50 years. Meanwhile our feature looked at the NHS Long Term Plan and asked to what extent mHealth will go towards solving the problems of the overstretched National Health Service.

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