[Updated, 9/28/18, 12:54 p.m. See below.] An Eli Lilly drug developed to prevent migraine headache pain before it starts has won FDA approval.
The FDA decision announced late Thursday marks the third drug in this new class of medicines to receive the regulatory nod this year. Two weeks ago, the FDA approved a migraine drug from Teva Pharmaceutical (NYSE: TEVA). Amgen (NASDAQ: AMGN) was the first, receiving FDA approval for its migraine drug in May.
The Lilly (NYSE: LLY) drug, galcanezumab (Emgality), is administered as a once-monthly self-injection. Like the Amgen and Teva medicines, galcanezumab is an antibody drug that blocks calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. CGRP inhibitors don’t prevent migraine attacks entirely, but in clinical trials they have been shown to reduce the frequency of headaches.
The FDA decision for the Lilly drug is based on three Phase 3 studies. Two of the studies tested the drug in patients who have episodic migraine, defined as four to 14 headaches per month, and one was for chronic migraine, which is 15 or more headaches per month. In the studies, Lilly reported that the reduction in the days per month that patients experienced migraine headaches was statistically significant. The most common side effect observed in the studies was a reaction at the site of the injection.
Lilly says it will make the drug available “shortly after approval.” The company set a list price of $575 monthly, or $6,900 annually, which is in line with the prices for the first two CGRP inhibitors approved, Amgen’s erenumab (Aimovig) and Teva’s fremanezumab (Ajovy). The non-profit Institute for Clinical and Economic Review, a drug price watchdog, has said that at that price level, the new migraine treatments are cost-effective, provided patients have first tried older and less expensive treatments. Lilly is also offering to provide its drug free for up to 12 months, as long as a patient’s physician submits a letter stating that the treatment is medically necessary. Patients will be able to obtain the Lilly drug from retail pharmacies.
[The following two paragraphs added with analyst comment.] In a research note, Evercore ISI analyst Umer Raffat observed that the other migraine drugs also have temporary free drug programs; Amgen’s is 12 months while Teva’s is 16 months. Based on patient feedback that Raffat has heard, the Teva and Lilly migraine drugs may have advantages over Amgen’s. Some patients treated with the Amgen drug have reported constipation, which is not listed as a side effect for either the Lilly or Teva drugs. Also, some patients whose symptoms have not responded to Amgen’s drug have expressed interest in switching to the Teva drug, though he added that there is no research to support the move.
The competition between Teva and Lilly is also taking place in another venue: the courts. Last year, Teva sued Lilly, claiming that the Indiana company’s migraine drug infringed five of its patents. Raffat said the federal court in Massachusetts dismissed the two Teva cases on Thursday. In response, Teva filed a new suit claiming infringement on nine patents for its drug.
Here’s more on the development of CGRP migraine drugs and concerns about the price of these treatments.