Expected to be approved in May! Amgen migraine new drug arrives at all end points of phase 3 April 19, 2018 Source: WuXi PharmaTech Recently, Amgen released the final results of a phase 3b clinical trial of the company's migraine drug Aimovig (erenumab) for patients with episodic migraine. These patients have received 2-4 other preventive therapies, but the symptoms have not improved. The trial data indicates that erenumab has reached the primary end point of clinical trials and all secondary endpoints, and it is possible to provide such patients with a therapy that is effective in preventing migraine attacks. Migraine is the most common cause of severe headaches in the world. The onset of the attack seriously affects the patient's daily life and work ability. According to the World Health Organization (WHO), it is the sixth leading cause of year lost due to disability (YLD) in the world. Migraine can be divided into paroxysmal migraine and chronic migraine according to its severity. Patients with paroxysmal migraine have fewer than 14 migraine attacks per month, while patients with chronic migraine have more than 15 episodes per month. Migraine not only brings physical pain to patients, but also deprives them of their ability to live and work healthily and expose them to a greater social burden. For patients who are often afflicted with migraine, the use of preventive therapy to reduce the number of migraine attacks is an important option for controlling the condition. The erenumab jointly developed by Anjin and Novartis is a humanized monoclonal antibody that targets the CGRP receptor, and activation of the CGRP receptor is associated with migraine attacks. Amgen has tested the efficacy and safety of erenumab in the prevention of migraine in several large clinical trials. More than 3,000 patients participated in a total of 4 clinical trials with Phase 2 and Phase 3 trials, as well as extended label extensions. Period test. In a multicenter, placebo-controlled, randomized, double-blind, clinical phase 3b trial called LIBERTY, 246 patients with paroxysmal migraine were randomized to receive a subcutaneous injection of erenumab or placebo once a month. The randomized double-blind trial period was 12 weeks. In the 9th to 12th week after the start of the clinical trial, 30.3% of the patients treated with erenumab had a reduction in migraine attack days by at least 50%, which was significantly higher than the control group (13.7%, p<0.002, the odds ratio was 2.73). ▲ Amgen is in the phase 3 R&D pipeline (Source: Amgen official website) At the same time, erenumab reached all secondary endpoints of this clinical trial, including a reduction in the number of migraine days per month, a reduction in the monthly use of acute migraine medications, and a reduction in the number of days of migraine attacks per month by more than 75%. The number of patients with a monthly migraine attack reduction of 100% and the improvement in their daily life and work ability. In terms of safety, 97% of patients treated with erenumab completed a randomized double-blind portion of the LIBERTY clinical trial. No patients in the erenumab group stopped treatment because of side effects, while 0.8% of the patients in the control group stopped treatment because of side effects. “The LIBERTY study clearly demonstrates the ability of CGRP receptor antibodies to significantly reduce the frequency of migraine attacks and the burden of related patients. The current preventive therapies have failed to alleviate the burden on these patients,†said Professor Uwe Reuter, medical director of Charité Universitätsmedizin in Berlin, Germany. “These convincing data are aimed at reducing the number of days of headache attacks for migraine patients who are not effectively treated between current standard therapies.†The US FDA has set a PDUFA action date for the erenumab biologics license application (BLA) on May 17, 2018. This means that this new drug for preventing migraine is expected to be approved in May this year for the benefit of migraine patients. We look forward to its good news! Reference materials: [1] Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of AimovigTM (erenumab) For Migraine Patients With Multiple Treatment Failures [2] Mayo Clinic: Migraine Organic Garlic Powder,Simply Organic Garlic Powder,Organic Garlic Powder Bulk,Organic Black Garlic Powder shandong changrong international trade co.,ltd. , https://www.changronggarliccn.com
