Significant milestone toward the commercialization of eptinezumab, the first quarterly infusion therapy for migraine prevention
BOTHELL, WA, USA I February 22, 2019 I Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a Q1 2020 commercial launch.
“Completing the BLA submission of eptinezumab is a significant milestone for Alder that underscores our continued mission to provide new treatment options for the millions of patients living with the debilitating effects of migraine,” said Bob Azelby, chief executive officer of Alder. “I’m extremely grateful to all the Alder staff, physicians and other medical professionals who participated in the BLA submission process with a common goal to support patients who are looking for additional preventive treatment options. If approved, eptinezumab will be the first quarterly infusion therapy for migraine prevention designed specifically for rapid, effective, and sustained suppression of migraine.”
Eptinezumab has been evaluated in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in both chronic and episodic migraine prevention. The BLA includes, and is supported by, positive data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open-label safety study, pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages. Top-line results from the PROMISE 1 and PROMISE 2 Phase 3 clinical trials were presented at the American Association of Neurology (AAN) and American Headache Society (AHS) meetings in the second quarter of 2018 and will be published in future peer-reviewed publications.
About Eptinezumab PROMISE Clinical Trial Program
PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for episodic migraine prevention. In the study, patients were randomized and 888 received eptinezumab (300 mg, 100 mg or 30mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at most 14 headache days per month, of which at least four met the criteria for migraine. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week treatment period. Secondary study endpoints assessed through 12 weeks include at least 75 percent and at least 50 percent responder rates, and proportion of patients experiencing migraine on the day following administration. In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 1 with very high statistical significance. See the press release for more information.
PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2) was a Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for chronic migraine prevention. In the study, patients were randomized and 1,072 received eptinezumab (300 mg or 100 mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at least 15 headache days per month, of which at least eight met criteria for migraine. Patients that participated in the trial had an average of 16.1 migraine days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week, double-blind treatment period. Secondary study endpoints assessed through 12 weeks included proportion of patients experiencing migraine on the day following administration and reduction of migraine prevalence days 1-28, reduction of at least 50%, 75%, and 100% from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in patient-reported impact scores on the Headache Impact Test (HIT-6). In January 2018, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 2 with very high statistical significance. See the press release for more information.
About Eptinezumab
Eptinezumab is an investigational monoclonal antibody (mAb) discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is designed with very high specificity and strong binding for rapid, robust, and sustained suppression of CGRP.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming the migraine treatment paradigm through the discovery, development and commercialization of novel therapeutic antibodies. Alder’s lead product candidate, eptinezumab, is a monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP) and is currently in late-stage clinical development for the prevention of migraine. Unlike other CGRP inhibitors, eptinezumab was specifically designed as an infusion therapy to address significant patient need. Alder is also developing ALD1910, a preclinical mAb that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) for migraine prevention. For more information, please visit www.alderbio.com.
SOURCE: Alder BioPharmaceuticals
Post Views: 28
Significant milestone toward the commercialization of eptinezumab, the first quarterly infusion therapy for migraine prevention
BOTHELL, WA, USA I February 22, 2019 I Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a Q1 2020 commercial launch.
“Completing the BLA submission of eptinezumab is a significant milestone for Alder that underscores our continued mission to provide new treatment options for the millions of patients living with the debilitating effects of migraine,” said Bob Azelby, chief executive officer of Alder. “I’m extremely grateful to all the Alder staff, physicians and other medical professionals who participated in the BLA submission process with a common goal to support patients who are looking for additional preventive treatment options. If approved, eptinezumab will be the first quarterly infusion therapy for migraine prevention designed specifically for rapid, effective, and sustained suppression of migraine.”
Eptinezumab has been evaluated in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in both chronic and episodic migraine prevention. The BLA includes, and is supported by, positive data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open-label safety study, pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages. Top-line results from the PROMISE 1 and PROMISE 2 Phase 3 clinical trials were presented at the American Association of Neurology (AAN) and American Headache Society (AHS) meetings in the second quarter of 2018 and will be published in future peer-reviewed publications.
About Eptinezumab PROMISE Clinical Trial Program
PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for episodic migraine prevention. In the study, patients were randomized and 888 received eptinezumab (300 mg, 100 mg or 30mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at most 14 headache days per month, of which at least four met the criteria for migraine. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week treatment period. Secondary study endpoints assessed through 12 weeks include at least 75 percent and at least 50 percent responder rates, and proportion of patients experiencing migraine on the day following administration. In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 1 with very high statistical significance. See the press release for more information.
PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2) was a Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for chronic migraine prevention. In the study, patients were randomized and 1,072 received eptinezumab (300 mg or 100 mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at least 15 headache days per month, of which at least eight met criteria for migraine. Patients that participated in the trial had an average of 16.1 migraine days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week, double-blind treatment period. Secondary study endpoints assessed through 12 weeks included proportion of patients experiencing migraine on the day following administration and reduction of migraine prevalence days 1-28, reduction of at least 50%, 75%, and 100% from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in patient-reported impact scores on the Headache Impact Test (HIT-6). In January 2018, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 2 with very high statistical significance. See the press release for more information.
About Eptinezumab
Eptinezumab is an investigational monoclonal antibody (mAb) discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is designed with very high specificity and strong binding for rapid, robust, and sustained suppression of CGRP.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming the migraine treatment paradigm through the discovery, development and commercialization of novel therapeutic antibodies. Alder’s lead product candidate, eptinezumab, is a monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP) and is currently in late-stage clinical development for the prevention of migraine. Unlike other CGRP inhibitors, eptinezumab was specifically designed as an infusion therapy to address significant patient need. Alder is also developing ALD1910, a preclinical mAb that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) for migraine prevention. For more information, please visit www.alderbio.com.
SOURCE: Alder BioPharmaceuticals
Post Views: 28
