The US Food and Drug Administration (FDA) has approved the
humanized monoclonal antibody fremanezumab-vfrm (Ajovy, Teva Pharmaceuticals)
for migraine prevention in adults, the manufacturer has announced.
The injectable calcitonin-gene-related peptide (CGRP)
antagonist "is the first and only anti-CGRP treatment for the prevention
of migraine with quarterly (675 mg) and monthly (225 mg) dosing options,"
the company said in a press release.
As reported by Medscape Medical News, in May the FDA
approved the self-injectable erenumab (Aimovig, Amgen and Novartis) as the
first CGRP antagonist for this indication. It's now offered as once-monthly 70-
or 140-mg single-use prefilled autoinjectors.
Stephen Silberstein, MD, director of the Jefferson Headache
Center at Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania,
noted in Teva's press release that the FDA's new approval of a second anti-CGRP
is good news for patients.
At the 2017 American Headache Society Annual Scientific
Meeting, investigators presented detailed results from two phase 3 studies of
fremanezumab.
More than 1000 patients with chronic migraine (CM) were
enrolled in the HALO-CM trial. Those who were randomly assigned to receive 675
mg of the active treatment for 1 month followed by either 225-mg dose
treatments for the following 2 months ("monthly dosing") or placebo
for the next 2 months ("quarterly dosing") had a significantly
reduced number of monthly headache days (4.6 and 4.3 days, respectively)
compared with those who received only three monthly placebo injections (2.5
days; P < .0001 for both comparisons).
In addition, 873 patients with episodic migraine (EM) were
enrolled in the HALO-EM trial. Both the monthly and quarterly dosing groups met
the study's primary endpoint of greater reduction in monthly migraine days at
12 weeks vs the placebo group (by 3.7 and 3.4 days, respectively, vs 2.2 days;
P < .0001).
The most common treatment-related adverse events were
injection-site reactions and infections, a statement from the FDA notes…
Teva reports that the treatment, which can be administered
in a physician's office or at home, will become available in about 2 weeks —
and notes that the US wholesale acquisition cost of the treatment is $575 per
monthly dose and $1725 per quarterly dose. However, the company notes that
"commercially insured patients may pay as little as $0 on prescriptions
until the offer expires."
In addition to fremanezumab and erenumab, two other
anti-CGRP antibody treatments are in various stages of development.
Galcanezumab (Lilly) is currently under review, with a PDUFA date listed as
"September 2018." The manufacturer of eptinezumab (Alder
BioPharmaceuticals) is expected to file for FDA approval by the end of 2018.
See: https://childnervoussystem.blogspot.com/2017/11/medication-trials-for-migraine.html
The US Food and Drug Administration (FDA) has approved the
calcitonin gene–related peptide (CGRP) antagonist galcanezumab-gnlm (Emgality,
Eli Lilly and Co) for the prevention of migraine in adult patients, the
manufacturer reports.
This marks the agency's third approval this year of an
anti-CGRP for this indication, following earlier approvals of erenumab
(Aimovig, Amgen and Novartis) and fremanezumab-vfrm (Ajovy, Teva).
The humanized monoclonal antibody also received recommended
marketing authorization from the European Medicines Agency's Committee for
Medicinal Products for Human Use last week.
The FDA's approval is for a 120-mg self-administered,
subcutaneous injection of galcanezumab. The recommended dose is 240 mg once as
a loading dose, administered in two consecutive injections of 120 mg each,
followed by monthly injections at 120 mg…
As reported at the time by Medscape Medical News, detailed
results from three phase 3 trials that assessed galcanezumab were presented at
the 2017 American Headache Society Annual Scientific Meeting.
In EVOLVE-1 and EVOLVE-2, which together included more than
1700 patients with episodic migraine, the participants who received 120 or 240
mg of the active drug experienced significantly greater reductions in monthly
migraine headache days than those who received matching placebo.
Similar results were shown in the REGAIN trial, which
included more than 1100 patients with chronic migraine.
Adverse events reported in the three studies included
injection site pain, reactions, and erythema.
The company reports that the US list price for the drug will
be $575 once monthly or $6900 annually. However, "patients with commercial
insurance are candidates to receive Emgality for up to 12 months free as part
of Lilly's patient support program," said the manufacturer.
See: https://childnervoussystem.blogspot.com/2018/06/galcanezumab-for-prevention-of-migraine.html
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