FDA Approves AbbVie’s Qulipta, SET to Become Blockbuster to Cure Migraine
The US Food and Drug Administration approved a new drug named Qulipta. AbbVie’s Qulipta got approval as a preventative treatment for migraines. The FDA approval has made AbbVie’s Qulipta the only brand that has three approved drugs for treating migraines.
AbbVie has developed this new drug named Qulipta as a preventative drug for healing migraines in adults. It is the one and only receptor antagonist present in the market for migraines. The company has released an official statement to let us all know about their new drug which has been approved by the US Food and Drug Administration.
AbbVie’s Submission to FDA
The company had already submitted the trial data to get approval from the FDA. The Food and Drug Administration has examined the efficacy, safety, and tolerability of this new drug. After analyzing the data and the submitted report, the Administration has officially approved this drug for migraines for adults in the United States.
How do AbbVie Conducted Trials of Qulipta?
Just like every other new drug, the company had invited volunteers who can help them test out the efficacy and safety of the drug. AbbVie has tested this medicine on over 2,000 patient who experiences migraines about 4 to 14 days in a single month.
The study report submitted to FDA was of all the phases including the Phase 3 Advance Study, the Pivotal Phase 2, the Pivotal Phase 2b/ 3. Along with this, they had also submitted the Phase 3 long-term safety study. AbbVie had submitted all types of data and information which are mandatory for getting approval of a new medicine or drug from the FDA.
Evaluation from the Studies
The studies conducted by AbbVie received mind-blowing results. The company noted that Qulipta has significantly reduced the effects of migraines in those who experience it for up to 14 days in a month. The studies conducted on different types of patients with different age groups show positive results.
AbbVie’s Qulipta starts reduction of migraines in 1-4 weeks instead of following the 12-week long treatment. The pivotal trial data shows those who have received AbbVie’s Qulipta experienced 50% to 100% reductions in migraines in 1-4 weeks after taking this drug. This was the study conducted on those with higher levels of migraines i.e. with up to 14 days.
About the Migraine Disease
Migraine is considered the most annoying disease. Unlike normal headaches, in migraines, the patient experiences severe pain in a particular part of the head. The pain is unusual as it feels like someone is throbbing your head constantly.
Although migraine is not a life-threatening disease, it can affect your day-to-day life. The diseases can change your entire lifestyle as you will not get a quality of life due to constant headaches.
According to a recent study, over a billion people across the globe are experiencing migraines. The level of pain could be different from patient to patient. If we talk about the US alone, there are over 39 million people experiencing migraines of different levels starting from 1 to 14 days in a month.
Drawbacks of Qulipta’s Study
As per the data published by AbbVie, those who have been receiving Qulipta to cure migraines have experienced constipation problems. This changes the frequency of the doses and the actual period of the treatment. This was the only drawback that AbbView found during their pivotal phase 3 trials of their new drug called Qulipta.
What are the outcomes?
The approval of AbbVie’s Qulipta is a big win for the company as the company has been working tirelessly to bring an effective drug for patients with migraines. Several companies have tried developing a drug for migraines; however, FDA had rejected them due to insufficient data on their drug’s efficacy, safety, and lack of other information.
AbbVie has several drugs up in the market and they are quite experienced in the field. They know how to get approval by following the correct procedure. For that reason, they have first collected the data of their drug with phase 1, phase 2, and phase 3’s long-term trial on over 2000 patients with different age groups and different levels of migraines.
Apart from Migraines, rheumatoid arthritis and atopic dermatitis are also the most common types of diseases with millions of patients across the globe. Unfortunately, there are no approved drugs available for these diseases. We hope to see an effective drug for these two diseases in the coming months by a trusted manufacturer like AbbVie.
AbbVie’s Future Plan
The company aims to develop as many packets of Qulipta as they can so that they can provide it to the needy across the globe. The company aims to reach over 1 billion-plus sale of their new drug in the coming months. Unlike other drugs for treating migraines, Qulipta is easy to consume. The other drugs are injectable so people used to avoid them.
If we talk about the dosing, Qulipta needs to be taken by the patient every single day; on the other hand, the other drug available for treating migraines requires you to take it every other day. The company plans to change the dosages of their drug. They will come up with a new dose that will be more effective. AbbView plans to release new data on an ongoing study and research in the coming weeks.