Date: 2018-09-20
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Emgality®
Compound: galcanezumab
Therapeutic area: CNS diseases - Neurological diseases
Action mechanism:
- monoclonal antibody. Galcanezumab (LY2951742) is a once-monthly subcutaneously injected calcitonin gene-related peptide (CGRP) antibody currently being studied as a potential treatment for the prevention of chronic and episodic migraine and cluster headache. Lilly's CGRP antibody is a biologic entity that binds and inhibits the activity of CGRP, a sensory neuropeptide thought to be associated with vasodilation, pro-inflammatory effects and pain signaling, all thought to be implicated in the pathophysiology of migraine and cluster headache.
Company: Eli Lilly (USA -IN)
Disease: prevention of migraine in adults
Latest news:
- • On September 20, 2018, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Emgality™ (galcanezumab) for the prophylaxis of migraine in adults who have at least four migraine days per month.
- The CHMP positive opinion was based on Phase 3 data from two clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN). In all three clinical trials (EVOLVE-1, EVOLVE-2 and REGAIN), Emgality™ reduced mean monthly migraine headache days in the first month and every following month in the treatment period compared to placebo. In EVOLVE-1 and EVOLVE-2, which studied patients with episodic migraine, the majority of patients (~60%) treated with Emgality achieved at least a 50 percent reduction, on average, in monthly migraine headache days in any given month (p<0.001) compared to 38.6% and 36% of patients on placebo in EVOLVE-1 and EVOLVE-2, respectively. In these studies, more than one-third of patients achieved at least a 75 percent reduction, on average, in monthly migraine headache days in any given month (p<0.001) compared to 19.3% and 17.8% of patient on placebo in EVOLVE-1 and EVOLVE-2, respectively. One in 7 patients (15.6%) were migraine headache-free in any given month in EVOLVE-1, on average (p<0.001) compared to 6.2% of patients on placebo.
- Emgality™ has been studied in more than 2,500 patients in clinical studies for migraine prevention. More than 1,400 patients were exposed to Emgality™ during the placebo-controlled Phase 3 studies, with less than 2.5% of patients discontinuing due to treatment-related adverse events.
- The FDA is currently reviewing Emgality™ for the preventive treatment of migraine in adults. A decision regarding approval is expected by the end of September 2018.
- • On December 11, 2017, Eli Lilly announced that the FDA has accepted a Biologics License Application (BLA) to review galcanezumab for the prevention of migraine in adults. Galcanezumab has been submitted for use as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe. Lilly announced the submission of the BLA on its third-quarter earnings call in October 2017.
- The application includes positive data from three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN), which evaluated 2,901 patients. In these studies, patients treated with galcanezumab experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to placebo. The most commonly-reported adverse events were injection site reactions, including pain.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE: 2018-09-20
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
- • On July 3, 2018, the Institute for Clinical and Economic Review released a Final Evidence Report and Report-at-a-Glance on three calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine attacks: erenumab (Aimovig™, Amgen/Novartis), fremanezumab (Teva), and galcanezumab (Eli Lilly). ICER's report was reviewed at a June 2018 public meeting of the California Technology Assessment Forum (CTAF). Panel members voted that evidence was adequate to demonstrate a net health benefit of the CGRP inhibitors for individuals with chronic migraine and no other available treatment options. While acknowledging the significant impact even infrequent migraine has on day-to-day life, a majority of Panel members pointed to the unknown long-term risks in voting that current evidence is inadequate to show a net health benefit of the CGRP inhibitors for individuals with episodic migraine.
- Panel members noted that the therapies may provide potential additional benefits beyond those studied in clinical trials, including reduced family/caregiver burden, a novel mechanism of action that may allow for successful treatment of patients without other options, and increased productivity. Further, the high severity and lifetime burden of illness, along with the significant uncertainty around long-term risks and the magnitude and durability of benefit, were noted as key contextual considerations that factored into CTAF's assessment of value.
- Voting on the long-term value for money of erenumab, the only CGRP drug with a publicly-available price, a majority of the panel voted that erenumab represents an intermediate value in adults with chronic migraine, and votes were split between intermediate and low long-term value for money when the drug is used for patients with episodic migraine.
- Following the voting session during the CTAF meeting, a policy roundtable of experts - including patient advocates, physicians, public and private payers, and drug manufacturers - convened to discuss the implications of the evidence for policy and practice. Key recommendations stemming from the roundtable discussion include:
- When responsible pricing is accomplished and the net price of CGRP inhibitors aligns with the estimated added benefit for patients, prior authorization criteria should be relatively streamlined and allow documentation of eligibility through a clinician statement that patients have attempted adequate trials of two to three other preventive therapies rather than requiring extensive submission of clinical documents.
- Following the example set by the launch of the first CGRP inhibitor, manufacturers should continue to exercise restraint and ensure net prices align reasonably with the added benefits for patients. Consideration of price increases in future years should be transparently justified by new clinical evidence of superior performance.Clinicians should be aware of the uncertainties in long-term efficacy and potential harms when prescribing CGRP inhibitors. The FDA has requested additional research into liver toxicity and risks for heart attack and stroke after exposure to erenumab, and into potential adverse effects when erenumab is used during pregnancy.
Is general: Yes
