FDA Approves AbbVie’s Qulipta

FDA Approves AbbVie’s Qulipta, SET to Become Blockbuster to Cure Migraine

The US Food and Drug Administration approved Qulipta, a new drug from AbbVie. It is a preventative treatment for migraines.

The FDA approval has made AbbVie one of the brands with multiple approved drugs for treating migraines, but it is not the only brand.

AbbVie has developed this new drug named Qulipta as a preventative drug for healing migraines in adults.

It is one of several receptor antagonists on 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 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.

In addition, they submitted the Phase 3 long-term safety study. AbbVie submitted all the data and information mandatory for getting FDA approval for a new medicine or drug.

Evaluation of the Studies

AbbVie’s studies received mind-blowing results. The company noted that Qulipta has significantly reduced the effects of migraines in those who experience them 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 can start reducing migraines within 1-4 weeks, part of the 12-week treatment assessment period.

The pivotal trial data shows that some participants who received AbbVie’s Qulipta experienced a 50% reduction in migraine days.

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 a highly debilitating disease. Unlike normal headaches, the patient experiences severe pain in a particular head part in migraines.

The pain is unusual as it feels like someone is throbbing your head constantly.

Although migraines are generally not life-threatening, they can significantly affect daily life and overall quality of life. The diseases can change your entire lifestyle as you will not get a quality of life due to constant headaches.

Estimates suggest that approximately 1 billion people worldwide experience 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

According to 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 its pivotal phase 3 trials of its new drug, Qulipta.

What are the outcomes?

The approval of AbbVie’s Qulipta is a big win for the company, which has been working tirelessly to develop 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 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.

Several approved drugs are available for rheumatoid arthritis and atopic dermatitis. In the coming months, we hope to see an effective drug for these two diseases from a trusted manufacturer like AbbVie.

AbbVie’s Future Plan

The company aims to develop as many packets of Qulipta as possible and distribute them to the needy worldwide.

The company aims for significant sales of its new drug in the coming months, though reaching over 1 billion sales in such a short timeframe is unrealistic. Unlike some other drugs for treating migraines that are injectable, Qulipta is an orally administered drug, which some patients may prefer.

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, coming up with a new dose that will be more effective. AbbView plans to release new data on ongoing studies and research in the coming weeks.

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Current Version
April 12, 2024
Updated By
Andrea Morales G.
October 1, 2021
Written By
Shubham Grover

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