Emgality™ – Eli Lilly and Company – FDA approval for the preventive treatment of migraine in adults

New Drug Overview – galcanezumab-gnlm (Emgality™)

On September 27, 2018, the U.S. Food and Drug Administration (FDA) approved galcanezumab-gnlm (Emgality™) for the preventive treatment of migraine in adults.  Galcanezumab-gnlm is the third calcitonin-gene related peptide antagonist to be approved for this indication this year after fremanezumab-vfrm and erenumab-aooe, approved on 9/14 and 5/17 respectively.  According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56 billion annually.  Eli Lilly and Company reports the U.S. list price of Emgality™ as $575 once-monthly, or $6,900 annually and will be offering a patient assistance program.

Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review
galcanezumab-gnlm Emgality™ Eli Lilly and Company September 27, 2018 Shortly after approval No
Labeled Indication
Preventive treatment of migraine in adults
Drug Class Comparative Drugs in Class Route of Administration Dosing Schedule
calcitonin-gene related peptide antagonist fremanezumab-vfrm erenumab-aooe Subcutaneous 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg
Mechanism of Action:
Monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, which works to block pathways that result in migraine activation
Clinical Trial Summary (Efficacy):
The efficacy of EMGALITY™ was evaluated as a preventive treatment of episodic or chronic migraine in three multicenter, randomized, double-blind, placebo-controlled studies: two 6-month studies in patients with episodic migraine (Studies 1 and 2) and one 3-month study in patients with chronic migraine (Study 3).

 

Study 1 (NCT02614183) EVOLVE-1 & Study 2 (NCT02614196) EVOLVE-2: adults with a history of episodic migraine

Study Dose: once-monthly subcutaneous injections of EMGALITY 120 mg, EMGALITY 240 mg, or placebo

Primary Outcome: mean change from baseline in the number of monthly migraine headache days

Initial assessment period: 6 months

Efficacy results are contained in the package insert for 1,311 patients

·         EMGALITY 120 mg demonstrated statistically significant improvements for efficacy endpoints compared to placebo

·         EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit over the EMGALITY 120 mg once-monthly dose.

 

Study 3 (NCT02614261) REGAIN: adults with a history of chronic migraine

Study Dose: once-monthly subcutaneous injections of EMGALITY 120 mg, EMGALITY 240 mg, or placebo

Primary Outcome: mean change from baseline in the number of monthly migraine headache days

Initial assessment period: 3 months

Efficacy results are contained in the package insert for 811 patients

·         EMGALITY 120 mg demonstrated statistically significant improvements for efficacy endpoints compared to placebo

·         EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit over the EMGALITY 120 mg once-monthly dose.

Warnings and Adverse Effects (AE):
Warning: Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions could occur days after administration, and may be prolonged
AE: The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions
NDC Strength Volume Presentation Storage
00002-1436-11 120 mg/ml 1 ml Carton of 1 prefilled pen Refrigeration
00002-1436-27 120 mg/ml 1 ml Carton of 2 prefilled pen Refrigeration
00002-2377-11 120 mg/ml 1 ml Carton of 1 prefilled syringe Refrigeration
00002-2377-27 120 mg/ml 1 ml Carton of 2 prefilled syringe Refrigeration
Drug Sales Forecast (in millions):
2018(F) 2019(F) 2020(F) 2021(F) 2022(F) 2023(F) 2024(F)
Emgality TM $23 $126 $281 $459 $623 $773 $922
                                       

 

References:

Global Data Pharma Intelligence Center https://pharma.globaldata.com Accessed October 15, 2018.

Eli Lilly and Company Press Release https://investor.lilly.com/news-releases/news-release-details/lillys-emgalitytm-galcanezumab-gnlm-receives-us-fda-approval Accessed October 15, 2018

RJ Health Systems Inc Reimbursement Codes https://www.reimbursementcodes.com Accessed October 15, 2018.

U.S. Food and Drug Administration Drugs@FDA: FDA Approved Drug Products Product Labeling https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf Accessed October 15, 2018.

 

Additional 2018 Pipeline Reviews are available in our pipeline library.

Please see the September 2018 FDA Actions Newsletter for additional information on recent FDA approvals.