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New Medicines

QuliptaEpisodic and chronic migraine - prophylaxis

Information

Qulipta
New molecular entity
Allergan
Allergan

Development and Regulatory status

None
Pre-registration (Filed)
Launched
Jul 22Filed in EU for prevention of chronic and episodic migraine. The EMA filing for atogepant covers the prevention of migraine in adults who have at least four migraine days per month [21].
Jun 22Filed in US for prevention of chronic migraine [21].
Mar 22Based on the results of the PIII PROGRESS trial, AbbVie intends to submit a supplemental New Drug Application (sNDA) with the U.S. FDA for the expanded use of atogepant to include the preventive treatment of chronic migraine. Additionally, study results from the trial, along with the PIII ADVANCE trial data, in episodic migraine, will form the basis for future regulatory submissions globally [20].
Oct 21Qulipta is available in the US in three strengths – 10mg, 30mg and 60mg [15,16].
Sep 21US FDA approve atogepant as a preventative treatment for episodic migraine headaches.[14]
Apr 21Filed with US FDA for approval.[12]
Jul 20Analysts predict US and ex-US launches in 2022, with 65% chance of success [11].
Mar 18Allergan expects to launch in the US in 2021 [8].
Mar 17Company expects launch to be in 2022 [2].
Sep 16PII/III dose-ranging study initiated (NCT02848326) [1].

Category

Calcitonin gene-related peptide (CGRP) receptor antagonist, orally-active small molecule taken once daily
Numbers may be misleading, as many who experience migraine do not consult their GP, but migraine affects about 6% of men and 18% of women. In children it is more common in boys than in girls. The first attack is often in childhood and over 80% have had their first attack by the age of 30 [3].
Episodic and chronic migraine - prophylaxis
Oral

Further information

Yes

Trial or other data

Jul 22PIII multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of atogepant (30mg BD or 60mg OD) for the prevention of chronic migraine (NCT03855137; PROGRESS) is due to complete. It started in Mar 19. The study will recruit 750 adult patients globally with at least a 1-year history of chronic migraine and a history of, on average, ≥ 15 headache days/month in the 3 months prior to Visit 1. Primary outcome measure is change from baseline in mean monthly migraine days over 12 weeks [19].
Jun 22Data from the PROGRESS study show that atogepant significantly reduced mean monthly migraine days with the 60mg once daily and 30mg twice daily doses during a 12-week period. A decrease of 6.88 and 7.46 monthly migraine days were reported, respectively, vs. placebo, corresponding to > 50% reduction in mean monthly migraine days. Data from this trial has been used to support the US filing. [5]
Apr 22Latest analysis of NCT03700320 shows that atogepant is effective as a long-term preventative treatment for the condition as 84% of trial pts experienced a 50% or greater reduction in monthly migraine days [17].
Apr 22Latest analysis of NCT03700320 shows that atogepant is effective as a long-term preventative treatment for the condition as 84% of trial pts experienced a 50% or greater reduction in monthly migraine days [17]
Mar 22AbbVie announced the PIII PROGRESS trial evaluating atogepant for the preventive treatment of chronic migraine in adults met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days vs placebo, for both the 60mg once daily and 30mg twice daily doses across the 12-week treatment period. The study also demonstrated that treatment with atogepant 60mg OD and 30mg BD resulted in statistically significant improvements in all secondary endpoints after adjustment for multiple comparisons. The overall safety profile of the study was consistent with safety findings observed in previous studies in an episodic migraine population [20].
Aug 21Results of PIII ADVANCE RCT reported in NEJM [13].
Aug 20PII/III NCT02848326) (n=1772 with 4–14 migraine days per month [MDPM]) found small reduction in MDPM with atogepant 10mg OD(-4.0), 30mg OD (-3.8), 60mg OD (-3.6), 30mg BD (-4.2) and 60mg BD (-4.1) compared to placebo (-2.9;p<0.05 all comparisons). Nausea & fatigue were most commonly reported ADRs [10].
Jul 20In PIII ADVANCE trial (n=910), patients treated with atogepant 10 mg/30 mg/60 mg experienced decrease of 3.69/3.86/4.2 days, respectively, in mean monthly migraine days, vs. a decrease of 2.48 days in patients on placebo (p<0.0001 all dose groups vs. placebo) [9].
May 19PIII extension trial to evaluate the safety and tolerability of atogepant 60mg once a day for the prevention of migraine in participants with episodic migraine starts (3101-309-002; NCT03939312). The open-label trial is enrolling approximately 750 patients in the US and is due to complete collection of primary outcome data in Nov 20 [7].
Jan 19A PIII, double-blind, RCT to evaluate the safety and tolerability of Atogepant 10mg, 30 mg and 60 mg (once daily) for the prevention of migraine in Participants with episodic migraine is currently recruiting (NCT03777059). This four arm study (three active comparators and one arm matched placebo) has a primary efficacy end point of change from baseline in mean monthly migraine days across the 12-week treatment period. The trial aims to enrol 872 patients. Estimated primary completion date February 2020. [6]
Nov 18A PIII, multi-centre, randomised, open-label study to evaluate the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with episodic migraine has started recruitment (NCT03700320). Estimated primary completion date June 2020. [6]
Jul 18Positive topline results from PIIb/III trial (CGP-MD-01; NCT02848326) showed a statistically significant reduction in mean monthly migraine days from baseline across the 12-week treatment period (primary efficacy endpoint). Atogepant met primary endpoints in across all doses and dose regimens. Efficacy analyses were based on the modified ITT (mITT) population of 795 pts. The trial evaluated the safety, tolerability and efficacy of oral atogepant for the prevention of episodic migraine in a randomised, double-blind, placebo-controlled trial which enrolled 834 pts to receive 10mg QID or 30 or 60mg QD or BID doses in the US. Atogepant was well tolerated. The most common adverse events were nausea, fatigue, constipation, nasopharyngitis, and urinary tract infection.[4,5]
Sep 16PII/III dose-ranging trial initiated (NCT02848326) - this double-blind, double-dummy trial will study doses of 10 mg, 30 mg, 60 mg, and 120 mg daily vs. placebo. Primary outcome will be mean number of migraine or probable migraine headache days from baseline up to last 28 days of the treatment period, estimated recruitment is 810, and estimated primary completion is November 2017 [1].

Evidence based evaluations