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 with 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 only receptor antagonist in the market for migraines.
The company has released an official statement to inform us about their new drug, which the Food and Drug Administration has approved.
AbbVie’s Submission to FDA
The company had already submitted the trial data for approval from the FDA. The Food and Drug Administration has examined this new drug’s efficacy, safety, and tolerability.
After analyzing the data and the submitted report, the Administration has officially approved this drug for migraines for adults in the United States.
How Does AbbVie Conducted Trials of Qulipta?
Just like every new drug, the company had invited volunteers who could help them test out the efficacy and safety of the drug.
AbbVie has tested this medicine on over 2,000 patients who experience migraines for about 4 to 14 days in a month.
The study report submitted to the FDA comprised all the phases, including the Phase 3 Advance Study, the Pivotal Phase 2, and 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 mandatory for getting approval for a new medicine or drug from the FDA.
Evaluation of 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 reducing migraines in 1-4 weeks instead of following the 12-week 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 head part.
The pain is unusual as it feels like someone is throbbing your head constantly.
Although migraine is not life-threatening, it can affect your daily 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 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, the FDA has 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 pretty experienced in the field. They know how to get approval by following the correct procedure.
For that reason, they 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 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 by a trusted manufacturer like AbbVie in the coming months.
AbbVie’s Future Plan
The company aims to develop as many packets of Qulipta as possible to provide it to the needy across the globe.
The company aims to reach over 1 billion-plus sales of its 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 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 its 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.