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Axsome’s late-stage study of experimental depression drug misses main trial goal

Photo by Tom Varco

Axsome Therapeutics reported on Monday that its Phase 3 study of its experimental depression drug missed its main trial goal.

It’s drug AXS-05 (dextromethorphan/bupropion) failed to significantly improve depression symptoms compared to bupropion, in patients with treatment-resistant depression (TRD). However this treatment for people with major depressive disorder (MDD) remains on track in its trial phase.

Teva's Ajovy becomes first drug of its kind available on NHS for prevention of chronic migraine

NICE has announced the authorisation of Teva’s anti-CGRP drug Ajovy (fremanezumab) for the prevention of chronic migraine in adult patients who have not responded to at least three prior preventive treatments.

The decision marks the availability via the NHS in England and Wales of the first preventative migraine therapy that offers quarterly and monthly options and can be self-injected with training.

Lundbeck's Vyepti secures US approval for migraine prevention

Lundbeck’s Vyepti (eptinezumab-jjmr) has secured approval from the FDA, it has emerged, for the prevention of migraine in adult patients.

The drug was tested in two Phase 3 trials, the first evaluating its efficacy in episodic migraine, and a second in chronic migraine.

FDA approves Teva's Ajovy autoinjector for treatment of migraine

Israeli pharma firm Teva has revealed that the FDA has chosen to award approval to its autoinjector device for the delivery of its Ajovy (fremanezumab-vfrm) solution, used to treat patients with migraine.

The approval means that US patients will now have access to a delivery option which lets them self-administer the drug. The device is expected to be made available “in the coming months”.

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.

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