Amgen Announces Five-Year Open-Label Study Confirming Long-Term Efficacy and Safety of Aimovig in Episodic Migraine

October 09, 2020 News /Bio ValleyBIOON/ -- Amgen recently presented long-term safety and efficacy data from the 5-year open-label treatment phase (OLTP) of a Phase 2 study (NCT01952574) evaluating Aimovig (erenumab) for the treatment of episodic migraine (EM) in adult patients at the 18th Migraine Trust International Symposium (MTIS 2020). The results showed that Aimovig not only helped patients achieve a sustained reduction in monthly migraine days, but also reduced the use of acute migraine-specific medications (AMSMs, such as triptans). Furthermore, the safety profile was consistent with observations during the double-blind treatment phase of the study, with no increase in the incidence of adverse events over the 5-year exposure period. These 5-year data further reinforce the established benefits of Aimovig for migraine patients.

Aimovig is the first migraine medication approved globally that targets the calcitonin gene-related peptide (CGRP) pathway. The drug is co-commercialized by Novartis and Amgen in the United States, while Amgen holds exclusive commercialization rights in the Japanese market.NovartisPossesses exclusive commercialization rights in regions outside of China.

These additional long-term data presented at the conference further solidify Aimovig’s position as the most widely used anti-CGRP medication. Since its launch, Aimovig has been prescribed to more than 440,000 patients worldwide.

This OLTP study (NCT01952574) evaluated the sustained efficacy and long-term safety of Aimovig 70 mg and 140 mg for the treatment of episodic migraine (EM), defined in the study as 4–14 monthly migraine days and <15 headache days at baseline. After completing the 12-week randomized, double-blind, placebo-controlled period (DBTP), 383 eligible adult patients with EM entered the open-label treatment period (OLTP). All patients initially received Aimovig 70 mg once monthly; following a protocol amendment to assess the long-term safety of the higher dose, 250 patients had their dose increased from 70 mg to 140 mg. Efficacy endpoints included changes from baseline in monthly migraine days (MMD) and days of acute migraine-specific medication (AMSM) use. Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory evaluations, and vital signs.

Data showed that among the 216 patients who completed the open-label treatment period (OLTP), the mean monthly MMD decreased by 5.3 days from the DBTP baseline of 8.7 days. By the end of the study, in patients treated with AMSM for migraine, the mean number of days of AMSM use per month decreased by 4.4 days from the DBTP baseline of 6.2 days. Compared with DBTP, no new safety signals or increased incidence of adverse events were observed during the 5-year treatment period with Aimovig. The safety and tolerability profile of Aimovig was consistent with otherClinical TrialThe data are consistent; the most common adverse reactions are nasopharyngitis, upper respiratory tract infection, and influenza.

At MTIS 2020ConferenceAmgen also announced data from other studies of Aimovig, including interim results from the LIBERTY open-label extension study, as well as efficacy and safety results from the EMPOwER study. These studies reinforce the safety and efficacy of Aimovig in patients with episodic migraine (EM) across diverse backgrounds.

The interim 2-year results from the open-label extension study of the LIBERTY trial (NCT03096834) demonstrated that Aimovig maintained sustained efficacy without an increased incidence of adverse events in patients with episodic migraine who had previously failed 2–4 preventive therapies.The results of the Phase 3 EMPOwER study (NCT03333109) highlight the efficacy and safety of Aimovig in adult patients with episodic migraine from Asia, the Middle East, and Latin America.

Darryl Sleep, M.D., Senior Vice President of Global Medical Development and Chief Medical Officer at Amgen, stated: “Among calcitonin gene-related peptide (CGRP) therapies, Aimovig has the longest duration of safety and efficacy trial data in migraine treatment. Many migraine patients live in fear of their next attack. As the U.S.”FDAAs the first approved CGRP therapy and the most frequently prescribed preventive treatment in its class, Aimovig continues to be at the forefront of migraine prevention and clinical research. These long-term results further demonstrate Aimovig’s potential to help millions of migraine patients who may be suitable for preventive therapy.”

Calcitonin Gene-Related Peptide (CGRP) is a neuropeptide that has been shown to be released during migraine attacks and is considered a trigger for migraine episodes. Currently, CGRP and its receptor have become hot targets for the development of migraine medications.

To date, four monoclonal antibody therapies for migraine targeting CGRP and its receptor have been launched; in addition to Vyepti, the other three include Amgen/NovartisAimovig (targeting the CGRP receptor), Teva's Ajovy (targeting CGRP),Eli LillyEmgality (CGRP-targeted). Regarding administration, Vyepti is administered via intravenous infusion every 3 months; Aimovig and Emgality are both administered via subcutaneous injection once monthly; Ajovy can be administered via subcutaneous injection either once monthly or once every 3 months.

In addition, some pharmaceutical companies are developing oral CGRP receptor antagonists. Currently marketed products include Allergan’s Ubrelvy (ubrogepant) and Biohaven’s Zydis ODT (rimegepant orally disintegrating tablets), both of which are indicated for the acute treatment of migraine with or without aura in adults. Notably, in October 2019,Eli LillyOral drug Reyvow (lasmiditan) approved in the United StatesFDAApproved for the acute treatment of migraine (with or without aura) in adults. This drug is a 5-HT1F agonist and represents the first new class of acute migraine treatments approved in two decades. (Bioon.com)

Original Source: Amgen Announces Five-Year Data That Reinforce The Safety And Efficacy Profile Of Aimovig? (erenumab-aooe) In Adult Patients With Episodic Migraine