FDA Approves Lilly Migraine Medication As First Treatment For Cluster Headaches

Eli Lilly and Co's migraine treatment Tuesday became the first drug to gain US approval to reduce the frequency of episodic headache attacks, the Food and Drug Administration said.

Negative skills belong to a new class of drugs called CGRP inhibitors, used to prevent or reduce the frequency of migraines. It competes with Ajovy's Teva Pharmaceutical and Amgen's Aimovig, all of which were approved a few months ago, creating a bitter battle to gain market share. Approving a second use could help Lilly differentiate Emgality from its rivals.

Cluster headaches are recurrent and intense migraines that can occur several times a day during a "cluster period". Lilly estimates that about 250,000 people suffer from this disease in the United States.

"Patients have not had many other treatment options available, or they use substances that have not yet been approved and that have proven their ability to combat episodic headaches. of clusters, "said Libby Driscoll, vice president of Lilly Reuters' neuroscience business unit.

The vast majority of cluster headaches are episodic. Seizures can last from seven days to a year, followed by periods of pain free remission for at least a month.

The others are classified in the chronic category, with attacks occurring for more than one year without a period of remission or with a remission lasting less than one month.

Unlike migraines, which tend to be more common in women, the disease is slightly more common in men.

The injected treatment is administered once a month for the duration of an aggregation period, which tends to last from two to ten weeks on average. Patients with cluster headaches will receive a monthly dose of 300 milligrams, compared to a dose of 120 mg per month for the prevention of migraine headaches.

The price of the drug will be the same as that of migraine per milligram, but the cost will vary depending on the duration of treatment. Migraines cost $ 6,900 a year.

Last month, Lilly said she was ahead of Amgen and Teva to attract new migraine patients. He seeks to capitalize on this benefit by pointing out that his therapy can completely prevent headaches in a small percentage of patients.