According to foreign media reports, with the continuous influx of new migraine drugs into the US market, the US Food and Drug Administration has now approved the first oral calcitonin gene-related peptide antagonist for the treatment of acute migraine.
In 2065438+early 2008, FDA approved the first CGRP antagonist to treat migraine. This landmark approval prompted the launch of a brand-new drug in the American market, which is used to block the key CGRP receptor in the brain, which is known to play a major role in the pathogenesis of migraine. Since then, several other CGRP antagonists have been approved, but these first-wave drugs are expensive and need to be injected.
Now the FDA has approved the first oral CGRP antagonist for the initial migraine attack. This new oral migraine drug, called Ubrelvy, is competing with its main competitor rimegepant.
The results of phase 3 clinical trial of Ulbrevy are not impressive. The trial usually reports statistically significant results, but people question the clinical significance of these results. The main measure of curative effect is whether migraine can be relieved within two hours after taking medicine, while the result of placebo is 1 1% to 14%.
The secondary index was defined as "relieving migraine symptoms related to the most headache within two hours", with only a slight improvement, indicating that the curative effect of this cohort was close to 40%. Although the placebo group reported nearly 30% efficacy problems, questions about clinical significance can still be raised again.
Observing these results and the initial phase 3 data of another oral CGRP antagonist rimegepant on the market, two neuroscientists published an article in Headache magazine last year, suggesting that this new drug called gepants is similar to "the emperor's new clothes".
"Are the effects of ubrogepant and rimegepant related in clinic? Their efficacy seems to be much lower than that of triptans, and also much lower than that of over-the-counter painkillers. Presumably, they are said to be superior to triptan in safety or tolerance, and may only be related to a few migraine patients. Therefore, we think it is reasonable to suggest that it is difficult to see the emperor's new Gepante. "
Thousands of Americans suffer from migraine every year, and analysts believe that the market for these new oral CGRP drugs will reach billions of dollars. Although there are doubts about the broader efficacy, the FDA still believes that these new drugs will help a large number of other patients, who currently have no treatment plan.
Billy Dunn, Acting Director of the Neuroscience Office of the Center for Drug Evaluation and Treatment of FDA, said: "Ubrelvy is an important new choice for acute treatment of migraine in adults, because it is the first drug of its kind that can be used for this indication. The FDA is pleased to approve a new treatment for migraine patients and will continue to cooperate with stakeholders to promote the development of safe and effective new treatments for migraine. "
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