FDA approves Qulipta (atogepant), a new preventive migraine drug
Atogepant (Qulipta) is a new migraine drug that was just approved by the FDA for the preventive treatment of migraines. It is the third drug in the family of gepants. Gepants block the CGRP receptor. CGRP is a chemical released during a migraine attack. In the past three years, the FDA approved four injectable preventive migraine drugs that also block CGRP. Gepants are taken by mouth.
The dose of atogepant is 10 mg, 30 mg or 60 mg taken daily, once a day. The primary efficacy endpoint in clinical trials was the change from baseline in mean monthly migraine days over the 12-week treatment period. There was a drop of 3.7, 3.9, and 4.2 in the number of mean monthly migraine days in the 10 mg, 30 mg, and 60 mg doses, respectively.
Side effects – assessed in almost 2,000 patients – were infrequent and mild. Nausea occurred in 5%, 6%, and 9% on 10 mg, 30 mg, and 60 mg respectively, constipation in 6% on all three doses, and fatigue or somnolence in 4%, 4%, and 6%.
Ubrogepant and rimegepant, two other gepants, were first approved to be taken as needed, whenever a migraine strikes. Rimegepant recently was also approved for the prevention of migraines. Even though gepants are very similar they often differ in how they work in an individual patient. Some of my patients find that ubrogepant works much better than rimegepant while for others the opposite is true. I am certain that some patients will find a big difference in the way rimegepant and atogepant work for them. This is why it is useful to have a few drugs in every therapeutic category.
Unfortunately, I cannot answer such specific questions. In general, mixing oral and injectable CGRP drugs is considered safe.
I’ve just started taking Qulipta because I’ve developed daily migraine while on Ajovy. My neurologist says that I have to stop taking Ajovy because it hasn’t been approved to take both at the same time and may be bad for my heart. Also, I can only take 5 Ubrelvy per month while on it. Ubrelvy has been the only thing working so far. I’m reluctant to discontinue the Ajovy even though it seems to have stopped working. What are your thoughts Dr. Mauskop? Thanks.
It is too early to tell.
I started taking Qulipta on Aug. 1,2022. I did not get my usual one week long per month of migraines for August,September, and half of October and all of the sudden was hit hard with the daily migraines multiple times a day for 8 days ….it felt like they may have even been worse headaches than usual….does this mean that Qulipta is not going to work for me ?
Qulipta might work even if Emgality doesn’t. Some patients take both.
My 19 year old daughter’s preventives have stopped working. She is on emgality. Is it possible that this drug might work when emgality has failed? I assume she wouldn’t take both, is that correct? Thanks!
Thank you, that’s good to know! I will contact my insurance.
Ubrelvy is not being tested for the prevention of migraines. Ubrelvy manufacturer also developed Qulipta specifically for the prevention. However, I’ve had some patients whose insurance approved 30 tablets of Ubrelvy a month.
Have you heard if Ubrelvy is being studied to become a preventative drug as well as abortive, the way Nurtec was? I take Ubrelvy and would rather stick with a drug I know. Plus, it seems to have a bit of a preventative effect for me when I do take it multiple days in a row