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Psiloscribe

Lilly & CGRP

4 posts in this topic

Here is some pretty big news.
Cluster Headache
Lilly's Galcanezumab Meets Primary Endpoint in Phase 3 Study Evaluating Galcanezumab for the Prevention of Episodic Cluster Headache
05/15/2018
INDIANAPOLIS, May 15, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. A statistically significantly greater percentage of patients treated with galcanezumab also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to placebo at Week 3, the gated secondary endpoint.
My statement:
"It is hard to articulate the devastating impact that cluster headache can have on those of us living with the disease. Many people living with cluster headache spend years searching for effective treatment options to help ease an excruciating level of pain," said Bob Wold, a patient living with cluster headache and founder of Clusterbusters, Inc. "We are very excited by these results and galcanezumab's potential as a new treatment option for people living with cluster headache, many of whom have spent years feeling ignored and alone in their struggle."
godsjoy777 and Rod H like this

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This is just delightful news....seems I've been waiting 30+ yrs to hear something like this!!!

Sorry if I missed this.....any idea when available? Any idea of cost? What is expected of the insurance companies re coverage?

Anecdotal...I was treated with another monoclonal antibody (Rituximab) for a completely different condition. It's been 2+ yrs now... and while I still get the occasional hit...and frequent shadows....it is completely different (and LESSER) than the previous years experiences  (which may be equally anecdotally tied to 'aging out of CH"...which I relied on in times of desperation.) Just seemed remarkably "coincidental"....

Best

Jon

Edit to add: I ask about cost because the Rituximab cost over $10,000 per infusion....18 times. 

Edited by jon019
godsjoy777 likes this

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The following may help address availability and cost.  Approval for episodic cluster headache should be only a few months away.

http://thehill.com/policy/healthcare/388250-fda-approves-drug-to-combat-migraines

The Food and Drug Administration (FDA) approved a new medication on Thursday designed to prevent migraines.

The drug, called Aimovig, produced by pharmaceutical giants Amgen and Novartis, is intended to be administered through a monthly injection, and would cost patients $6,900 annually, Amgen said

The drug blocks a protein fragment called CGRP, which is believed to play a critical role in migraines, the company said. 

Amgen said it expects to make the drug available to patients in the U.S. within a week.

Aimovig is the first drug designed to treat the severe headaches experienced by millions of Americans. Trials of the medication showed many patients experiencing at least a 50 percent reduction in the number of days they experienced a migraine.

The condition can be debilitating for those who suffer from it. It not only causes severe headaches, but is often accompanied by nausea, vomiting and aversion to light, and can last for days.

"The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine," Sean Harper, Amgen's executive vice president of research and development, said in a statement.

jon019 and Shabi like this

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