In July, Novartis announced that additional data from a Phase III study confirmed that Aimovig 140 mg decreases the number of monthly migraine days (MMD) as well as migraine-specific medication days (MSMD), supporting the long-term efficacy of Aimovig for patients who have struggled to find effective preventive therapies specifically designed for migraine.Ĭost and competing for formulary coverage have been cited as potential obstacles for CGRPs. Amgen and Novartis do look at the number of migraines a patient has each month, but the companies say the most critical measure for Aimovig is impact on quality of life and how debilitating migraine days are. “On top of cutting the number of migraine days, patients were able to reduce the use of migraine-specific medication,” Emilie Grand-Perret, VP and head of Aimovig marketing, Novartis, told Pharm Exec, adding that the drug was studied in a variety of patient populations for episodic and chronic migraine. In clinical studies, Aimovig proved to decrease the number of migraine days, with a 50% reduction for some patients. A recent report by the Pharmacy Benefit Management Institute (PBMI) found that direct healthcare costs for patients with migraine were estimated at $2,571 higher than those for similar patients who don’t experience migraine. Symptoms can range from nausea, vomiting, sensitivity to light and/or sound and can be elicited by stress, anxiety, hormonal changes, bright or flashing lights, lack of food or sleep, and dietary substances. The International Headache Society diagnoses migraine based on the pain and frequency of attacks, at least five a month, that last anywhere from four to 72 hours. The costs of treating this population have been estimated at $22 billion annually. It affects 39 million men, women, and children in the US (one billion globally) and can be incapacitating. Migraine is the sixth-most disabling illness worldwide, according to the Migraine Research Foundation. Launch, approximately 225,000 patients have been prescribed Aimovig. ![]() The recommended dose is typically 70 mg but is also available in 140 mg it’s injected into the upper arm, thigh, or abdomen. The drugs in this class have been specifically developed to prevent migraines, in contrast to the antiseizure, antidepressant, and blood-pressure-lowering medications that have been traditionally used for prevention.Īimovig is self-administered once monthly using the SureClick autoinjector. The latter could become the first oral CGRP to hit the market. Earlier this year, FDA accepted new drug applications for Alder BioPharmaceuticals’ eptinezumab and Allergan’s ubrogepant. Since then, the market has grown considerably, with the approvals of Lilly’s Emgality and Teva’s Ajovy. Rather than treating symptoms once they appear, the subcutaneous injection targets the calcitonin gene-related peptide (CGRP) receptor that is believed to play a role in the inflammatory processes that bring on migraines.Īimovig was the first drug to be approved in the new class of CGRP monoclonal antibodies. In May 2018, FDA approved Aimovig (erenumab-aooe), a Novartis and Amgen collaboration for migraine prevention. ![]() Whether commercial firsts or important franchise expansions, these treatments all share unique paths to market entry-and tie strongly to the industry’s broader product launch landscape. Instead of recognizing the “Brands of the Year,” the theme is new beginnings and new promise, spotlighting five products with compelling product launch stories. Pharm Exec’s annual feature profiling a selection of notable biopharma brands is switching gears in 2019.
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