Could these clinical results mean a win for AbbVie shareholders?

At the beginning of this month, the pharmaceutical giant AbbVie (NYSE: ABBV) reported the results of its Phase 3 clinical trial of Atogepant for the preventive treatment of migraines in adults who met the criteria for episodic migraine.

Let’s take a look at why the results of the study could soon lead to US Food and Drug Administration (FDA) approval, and what impact that would have on AbbVie and its shareholders.

Image source: Getty Images.

A common disease

Before we go into the results of the phase 3 clinical study of atogepant, let us first discuss the prevalence of migraines and the differentiation between the various frequencies of migraine diseases.

Migraine is a neurological disease with often incapable neurological symptoms. Secondary symptoms such as nausea, vomiting, and sensitivity to sound, light, touch, and smell often accompany the characteristic symptom of a migraine, which is a severe, throbbing pain that is typically on one side of the head.

Migraines can be divided into three categories according to their frequency. Migraines that occur less than 10 days per month are known as low-frequency episodic migraines. Migraines that occur 10-14 days per month are diagnosed as high frequency episodic migraines. Finally, migraines that occur for at least 15 days per month are classified as chronic migraines.

It is estimated that 17.1% of American women and 5.6% of American men have episodic migraines, while 1.3% of women and 0.5% of men in the United States have chronic migraines.

Perhaps the most important piece of information about episodic migraines is that optimal treatment is the greatest predictor of whether a patient will progress to a chronic migraine.

The American Headache Society found that only 2.5% of patients who received “maximum treatment optimization” to control their episodic migraines progressed to chronic migraines the following year. Treatment optimization is maximized when a patient’s migraine headache is controlled so effectively with available treatment options that the migraine affects his or her life as little as possible. This is in stark contrast to the 8.1% of patients who received “very poor” treatment who progressed to chronic migraines in the following year. In other words, the treatments these patients are receiving are not doing an adequate job of correcting the disturbances in their lives caused by migraines.

A sensible reduction in the number of monthly headache days

Atogepant has been shown to be an effective treatment for the prevention of episodic migraines, which is supported by the data from its Phase 3 study.

Patients treated with 10 milligrams, 30 milligrams and 60 milligrams of Atogepant once daily reported a corresponding reduction in mean or mean monthly headache days of 3.9 (from a previous baseline of 8.4), 4 (8 , 8 baseline) and 4.2 (9 baseline), all of which were significantly higher than the 2.5-day reduction in the placebo group (8.4 baseline).

During the 12-week treatment period, 55.6%, 58.7% and 60.8% of patients who received 10 mg, 30 mg and 60 mg of Atogepant once daily achieved at least a 50% reduction in monthly migraine days.

The drug was also well tolerated in the phase 3 study. While patients receiving Atogepant were more likely to complain of constipation (6.9–7.7% versus 0.5% for placebo), nausea (4.4–6.1% versus 1.8% for placebo) and urinary tract infections ( 3.9-5.7% versus 4.5.). % for placebo), most of these symptoms were mild to moderate. Contrary to the drug’s potential benefit in reducing the number of monthly migraine days, this resulted in a low dropout rate with Atogepant.

Potential to acquire market share in a growing market

AbbVie expects a regulatory decision from the FDA in the third quarter ending September 30th. Given the effectiveness of Atogepant and the mild side effects associated with the drug, I believe FDA approval for Atogepant is imminent.

This would greatly complement AbbVie’s existing migraine drug portfolio, which consists of Botox (used to treat chronic migraines, among other things) and Ubrelvy (used to treat, but not prevent, acute migraines).

Once approved by the FDA, atogepant could gain a share of a global migraine drug market that research firm Market Data Forecast expects to grow 4.9% annually, from $ 4.4 billion in 2021 to 5.6 Billion US dollars by 2026.

Atogepant’s Phase 3 results lead me to believe that the drug could realistically achieve a 15% market share, which would translate into annual sales of around $ 800 million by 2026, with an additional $ 800 million in annual sales in five years would be significant.

Atogepant is one of many promising drugs for AbbVie

The deputy chairman Dr. Michael Severino noted during AbbVie’s second quarter 2021 conference call that AbbVie and Boehringer Ingelheim’s immunology drug Skyrizi is still on track to file its FDA approval application for an indication of Crohn’s disease in the coming months.

Given that Skyrizi nearly doubled its first-half sales from $ 630 million in 2020 to $ 1.25 billion in 2021 with its 34% market-leading share of psoriasis patients, another clue could be on a multi-billion dollar market for drug growth.

Meanwhile, AbbVie and Johnson & Johnson‘s blockbuster oncology drug Imbruvica posted 5% year-over-year growth from $ 2.52 billion in 2020 to $ 2.65 billion in 2021. AbbVie expects its combination Imbruvica and Venclexta will be approved next year for the treatment of both stage 1 chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma, which should also lead to future growth for the two oncology drugs.

AbbVie’s strong drug portfolio and its S&P 500-The dividend yield of over 4.3% offers income investors a safe dividend with potential for future growth, which I think makes the stock a buy right now.

This article represents the opinion of the author who may disagree with the “official” referral position of a premium advisory service from the Motley Fool. We are colorful! Questioning an investment thesis – even one of our own – helps us all think critically about investing and make decisions that will help us get smarter, happier, and richer.