dm+d

37504511000001103

Refrigerated Storage

Emgality Eli Lilly

Eli Lilly
Emgality
120mg solution for injection in pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:
Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to 30°C. If these conditions are exceeded, the pre-filled pen must be discarded.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

No if exposed to the conditions above
Yes, if exposed to the conditions above
11 November 2021
London MI Service

Lactation Safety Information

Caution
Propranolol; Metoprolol
For prophylaxis of migraine
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract, although very long half-life increases risk of accumulation in breastfed infant
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
22 January 2020

New Medicines

EmgalityPrevention of chronic or episodic migraine in adults

Information

Emgality
New molecular entity
Eli Lilly
Eli Lilly

Development and Regulatory status

Launched
Launched
Launched
July 2019
Jul 19Launched in the UK. Pack size 1 x single pen. Price £386.50 per single pen [19].
Mar 19Launched in Europe; countries not stated & has not yet been launched in the UK [18].
Nov 18Launched in the US [17]
Nov 18Approved in the EU [16].
Sep 18Approved in the US with a list price of $575 once-monthly, or $6,900 annually [14,15].
Sep 18Recommended for EU approval by CHMP - the full indication is "for the prophylaxis of migraine in adults who have at least 4 migraine days per month”. It is proposed that it be prescribed by physicians experienced in the treatment of migraine [13].
Dec 17Filed in US [12].
Nov 17Filed in EU via centralised procedure [11].
May 17US filing (but not EU) planned for 2017 [9].
Jan 16Lilly reports that PIII development is underway [5].
Jun 15CGRP is a potent vasodilator and is involved in neurogenic inflammation and pain signalling. It is released from neurons and acts locally on smooth muscle in blood vessels causing with the headache associated with migraine. The CGRP antibody is a humanised monoclonal antibody that selectively binds to and inhibits the activity of CGRP [1,2].

Category

Humanised monoclonal antibody that selectively binds to and inhibits the activity of calcitonin gene-related peptide (CGRP) [1,2].
Migraine affects about 6% of men and 18% of women [4]. The World Health Organization places migraine as one of the 20 most disabling illnesses. It is estimated that 13% of migraine sufferers (in the US) report using a daily preventive migraine medication [2].
Prevention of chronic or episodic migraine in adults
Subcutaneous

Further information

Yes

Trial or other data

Jun 21Eli Lilly announce start of a PIV head-to-head study comparing galcanezumab-gnlm (120mg once-monthly with 240mg loading dose) with oral rimegepant 75mg taken every other day. The multi-site, randomised, double-blind, double-dummy, parallel-group study will include pts who meet the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of episodic migraine with or without aura. The primary endpoint is 50% reduction in monthly migraine headache days and enrollment will begin later this year.[21]
Aug 19In a PIII study by Lily, galcanezumab met primary and all key secondary outcomes for efficacy and safety in patients with previous failures on two to four different standard-of-care migraine preventive medication categories. Galcanezumab cut the number of days patients experienced migraines per month by 4.1. The drug showed a 3.1-day improvement over placebo. [20]
Oct 18Four CGRP inhibitors are in development - galcanezumab, erenumab, fremanezumab (TEV-48125) and eptinezumab (ALD403). Data presented at the American Headache Society conference indicates they offer similar activity, so their developers will have to rely on factors other than their clinical profiles if and when they come to market [10].
May 18Results of EVOLVE-1 (NCT02614183) published in JAMA [13].
Jun 17Lilly presents more detail from PIII studies. In EVOLVE-1 and EVOLVE-2, a 50% reduction was seen in around 60% of patients on galcanezumab versus 36%-39% of placebo users, with all migraine attacks eliminated in 12%-15% and 6%, respectively. Similarly, the REGAIN study in chronic migraine saw the drug hit the 50% reduction threshold in around 28% of patients, compared to 15% of the placebo group [10].
May 17EVOLVE-1 & 2 and REGAIN are on-going but have all completed recruitment with completion expected Q2/3 17 [7].
May 17In the two six-month PIII trials patients with episodic migraine treated with galcanezumab (120 mg or 240 mg) experienced a greater decrease in the number of monthly migraine headache days compared to those treated with placebo. In EVOLVE-1 there was a mean reduction of 4.7 days for 120 mg and 4.6 days for 240 mg compared to an average reduction of 2.8 days for placebo, (p < 0.001, both groups). In EVOLVE-2: there was a mean reduction of 4.3 days, 4.2 days for the two doses and 2.3 days for placebo (p < 0.001). In the REGAIN study the figures were 4.8, 4.6 and 2.7 days respectively [8].
Dec 15PIII EVOLVE-2 study (NCT026141960 starts. The main purpose of this study is to evaluate the efficacy of LY2951742 in 825 adults with episodic migraine. Patients will be recruited in Argentina, Brazil, Czech Republic, Germany, Spain, UK, Israel, South Korea, Mexico, Netherlands, Taiwan & US. Collection of primary outcome data (change in number of monthly migraine headache days) is expected to complete in Jun 17 [6].
Nov 15A PIII safety study (NCT02614287) begins, & will involve 250 adults. Collection of data should be complete Sep 17 [6].
Nov 15PIII EVOLVE-1 study (NCT02614183) starts. The main purpose of this study is to evaluate the efficacy of LY2951742 in 825 participants with episodic migraine, recruited in the US & Canada. The primary outcome is change in number of monthly migraine headache days; collection of these data should complete Feb 17 [6].
Nov 15PIII REGAIN study (NCT02614261) begins. The main purpose of this study is to evaluate the efficacy of LY2951742 in 825 adults with chronic migraine. Patients will be recruited in US, Argentina, Brazil, Canada, Czech Republic, Germany, Italy, UK, Israel, Mexico, Netherlands, Taiwan & Spain. Collection of primary outcome data (change in number of monthly migraine headache days) is expected to complete in Feb 17 [6].
Jun 15LY2951742, a CGRP neutralizing antibody, for prevention of migraine met the primary endpoint in a PIIb study to prevent episodic migraine (4-14 headache days/month). The randomised, double-blind, placebo-controlled study (NCT02163993) evaluated the efficacy and safety of four doses of LY2951742 or placebo given in a once-monthly as a SC injection to 402 pts in the US with episodic migraine for 3 months. The study is objective was to assess superiority over placebo and the primary endpoint will be the mean change from baseline in the number of migraine days during the last 28-day period of the 3 month treatment phase. Eli Lilly and Company announced that LY2951742 met the primary endpoint in episodic migraine. LY2951742 demonstrated a statistically significant reduction in migraine headache days and a good safety and tolerability profile. Lilly will present data from this trial in a late-breaking session at the 57th Annual American Headache Society meeting on June 20th 2015. Full results are expected after August 2015 [1-3].

Evidence based evaluations

EmgalityChronic or episodic migraine in children and adolescents aged 6 to 17 years

Information

Emgality
Licence extension / variation
Eli Lilly
Eli Lilly

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

LY2951742 is a humanised monoclonal antibody that selectively binds to and inhibits the activity of calcitonin gene-related peptide (CGRP)
Migraine is the most important cause of headache leading to a decrease in the quality of life in children and adolescents. It is more common in boys than in girls until after the menarche, when it becomes more common in girls. Chronic migraine affects 0.8-1.8% of adolescents and 0.6% of children [1].
Chronic or episodic migraine in children and adolescents aged 6 to 17 years
Subcutaneous injection