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Migraine Market Gets Competitive With Second, Third CGRP Inhibitor Launches

 
• By Mandy Jackson

CGRP inhibitors were a hot topic during third quarter earnings calls, with Amgen and Teva talking about reimbursement progress, while Lilly marked progress for its add-on treatment, Allergan calmed fears about Botox's migraine sales, and Alder said its intravenous drug is on track.

Migraine word written on wood block

The launch of the CGRP inhibitors marked the biggest shakeup in the migraine market since the triptans started going generic – and the sponsors were pushed during their third quarter earnings calls for details that can help clarify the competitive landscape.

Amgen Inc.'s and Novartis AG's Aimovig (erenumab), which the FDA approved in May, is the only CGRP inhibitor...

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Madrigal Regains Lead With Rezdiffra MASH Approval In EU

 
• By Joseph Haas

Four days after Wegovy became the second approved MASH therapy in the US, Rezdiffra gets the first European approval. Plans are for an initial launch in Germany.

Wegovy’s Win In MASH Gives Novo A Much-Needed Edge Over Lilly

 
• By Manas Mishra

Just days after discontinuing a Phase III trial for a separate MASH compound, Novo Nordisk has secured the US FDA’s accelerated approval for Wegovy to treat the fatty liver disease.

Pipeline Watch: Seven Approvals And Five Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Tonix Ready To Revive Fibromyalgia Market With Tonyma

 
• By Joseph Haas

The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.

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Celldex Bullish On Barzolvolimab Despite Study Miss

 
• By Kevin Grogan

All eyes on chronic urticaria after eosinophilic esophagitis disappointment.

BioNTech/BMS Bispecific Shows Early Promise In Small Cell Lung Cancer

 
• By Andrew McConaghie

An updated abstract from the World Conference on Lung Cancer has given analysts confidence in BioNTech’s VEGF-A/PD-L1 bispecific challenger

DMD Plans Remain Central For Regenxbio Despite Hunter Syndrome FDA Approval Delay

 
• By Manas Mishra

All eyes will be on Regenxbio's DMD data, expected next year, as the drug developer navigates a three-month delay to its FDA approval hopes for its Hunter syndrome gene therapy.