FDA approves the use of first drug developed to treat chronic migraines

The FDA has approved the first drug to prevent migraines

Aimovig (erenumab) has been cleared by the USA regulator as a once-monthly, self-injected preventive treatment for migraines based on data from three clinical trials which showed the drug was able to reduce the number of migraine days in a month compared to placebo.

The drug, Aimovig, belongs to a class called anti-CGRP drugs, short for calcitonin gene-related peptide receptor.

The stock prices of Amgen (amgn) and Novartis (nvs) have popped after the pharmaceutical companies won US approval for a new shot that treats migraines.

"Cluster headache can be hard to evaluate in clinical studies, which has contributed to few available treatment options for clusterheadache, often considered the most severe pain one can experience", noted Christi Shaw, president of Lilly Bio-Medicines, in the release.

The wave of new treatments, of which Aimovig is the first to get approval, are going after the huge migraine market. In the second (n=577) and third (n=667) studies, in which patients had a history of chronic migraine, subjects experienced one fewer migraine day and 2-1/2 fewer migraine days, per month on average, respectively.

The FDA has approved the first drug to prevent migraines
FDA Approves Aimovig for Migraine Prevention

Amgen codeveloped Aimovig with Novartis, and are one of four companies pursuing regulatory approval of CGRP inhibitors for the prevention of migraine.

In a statement on Thursday, Express Scripts said migraine patients have a serious unmet need, but "not everyone will need this drug" and it will have a program in place to make sure the medication is authorized for only the appropriate patients.

The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials.

Injection site reactions and constipation were the most common adverse reactions in clinical studies of Aimovig. The companies expect approval in the European Union in the coming months. Compared to a placebo, Aimovig also resulted in a significant reduction in the use of acute migraine medications. "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine". Although some sufferers respond to safe, easily available painkillers, untreatable migraines represent one of the major causes of disability in the developed world.

As a migraine treatment Botox costs around $3,500 per year, and analysts predict that the annual price for Aimovig will drop to around $5,000 with rebates and discounts.

More news: Ebola cases on rise, reach 14 in DRC

Related News:

Most liked

FA Cup Final Preview
Gary Cahill has been back in favour in recent weeks and Chelsea have looked more solid with him in the middle of defence lately. Mourinho has at least ensured Champions League qualification for next season via a second-place finish in the Premier League .

Solar-powered iPhone X 'Tesla' made by Caviar costs United States dollars 4500
The iPhone X Tesla device costs a whopping $4,500, but could set the stage for the next generation of smartphones. The company has not specified the specs of the solar panel system and how much more battery life one might gain.

Denuclearization, sanctions, peace: Issues facing Trump-Kim summit
North Korea has given concessions by releasing US detainees and setting a date for the dismantling of its nuclear test site. State Department says the U.S. has not heard anything directly from Pyongyang or Seoul that would change that.

Cambridge Analytica files for bankruptcy after data scandal
Facebook has accused Cambridge Analytica of misappropriating its user data by violating terms of the data agreement with Kogan, the academic researcher.

No Man's Sky NEXT Update Will Bring Full Multiplayer In July
The premier feature of the May 2018 Xbox One update is added support for 120Hz displays. The Xbox One version will also come with the No Man's Sky NEXT update as standard.

What You Need To Know From Walmart's Q1 Report
The firm has a market cap of $258,586.33, a P/E ratio of 19.78, a price-to-earnings-growth ratio of 3.18 and a beta of 0.54. Sam's Club membership fees and other income for the quarter totaled $1.06 billion, an increase of 4.3% year over year.

US Air Force apologizes for 'Yanny or Laurel' Afghan war tweet
Laurel Halo, meanwhile, got defensive against those who weren't teaming on the side of her namesake. But the computerized clip turned into an insensitive humour when the U.S.

Obama FBI 'Probably' Had a Spy Inside Presidential Campaign
During a Thursday (Friday NZT) interview on Fox & Friends, Giuliani, a former NY mayor, called for an end to the Mueller probe. But media attention has largely been on the allegation of collusion between Russian Federation and the Trump campaign.

Congo receives first doses of Ebola vaccine amid outbreak
Patta also reports that a crucial difference between the two outbreaks is the speed at which worldwide agencies have responded. It brings to 35 the number of reported cases, including two confirmed, according to the World Health Organization tally.

Nokia X6 may come to India, teases HMD chief Juho Sarvikas
Shortly after that, a new variant of the device was spotted , triggering speculations that it's the global model . With a software update, Xiaomi Redmi Note 5 Pro is also tipped to receive this feature in the future.

Coach Guardiola signs contract extension with Man City
Jose Mourinho "deserves some accolades" for finishing second behind Pep Guardiola in the race to win the Premier League title this season.

'Restless' Firmino eyes Champions League glory with Liverpool
All of the players signed shirts for the 50 guests present before asking questions on the Champions League final against Liverpool .

Disclosure report shows Trump earned $40M in 2017 from DC hotel
The FBI and Secret Service are now involved in an investigation after a gunman opened fire in the Trump National Doral Miami. Officers exchanged gunfire with the suspect, who was shot multiple times in the lower extremities and taken into custody.

Kilauea Eruption Prompts US Senate Action On Volcano Monitoring
Houghton says that it may be hard to know when it is safe for people to return to evacuated areas. Lisa Murkowski said in a statement after Thursday's vote.

Sanctions on Iran and Venezuela May Empower US Rivals
The position holds to the Justice Department's view on the possibility of prosecuting a sitting president. As a result of its surging production, USA crude is increasingly appearing on global markets as exports.