September may be the month we see competition in the Anti-CGRP monoclonal antibody drug class. Two Investigational drugs in the Pharmaceutical Pipeline Tracker’s knowledgebase have PDUFA Dates during September. This will bring competition for erenunab (Aimovig), which was approved and launched in May. Both fremanezumab and galcanezumab are monoclonal antibodies that bind to calcitonin gene-related peptides.
Teva’s Fremanezumab with a PDUFA Date of September 16, 2018, due to its Fast Track status. It’s seeking approval for migraine prophylaxis. Teva's PDUFA date was delayed from June to September due to its API provider, Celltrion, receiving an FDA warning letter for manufacturing issues. Celltrion received a second warning letter from the FDA after a July 2018 inspection revealed problems with employee training quality control protocols. If the FDA delays the PDUFA date, it would potentially move fremanezumab to be the third approved product, instead of the second. In early September, Teva still felt the drug would be approved by the mid-September date.
Lilly’s Galcanezumab with expected approval by the end of September 30, has Fast Track status for cluster headache. It’s indicated for migraine prophylaxis. Lilly plans to offer an auto-injector for galcanezumab like erenumab. Fremanezumab is a more viscous solution and will initially be offered as a prefilled syringe. So, while the drug may be approved as a quarterly subcutaneous injection, it may require a visit to a physician's office for administration, while monthly doses of galcanezumab and erenumab can be administered by the patient. Teva is working on an auto-injection system for fremanezumab, but it is not known when it will be available.
One other Anti-CGRP monoclonal antibody investigational drug exists: Alder Biopharmaceuticals’ eptinezumab, which is administered every three months by IV infusion. Alder plans to file a BLA in the second half of 2018. Alder has the ongoing PROMISE-2 study involving chronic migraine patients. Erenumab is available as an auto-injector for monthly sub-Q injection.
ICER released a final review of CGRP inhibitors on July 3, 2018. ICER found insufficient evidence to recommend erenumab or fremanezumab over oral preventative drugs or botulism toxin for prevention of migraine in untreated patients. ICER did find evidence of a benefit for use of erenumab or fremanezumab in patients that had previously failed preventative therapy for chronic migraine. Data was supportive but inconclusive for prevention of episodic migraine. ICER found insufficient evidence for use of galcabezumab in either indication. ICER estimated that CGRP inhibitors would improve quality of life years (QALY) for episodic and chronic migraine patients. The estimated cost per QALY were lower for chronic migraine compared to episodic migraine. ICER felt that insurers would be justified in setting limits or restrictions on CGRP inhibitors due to insufficient long-term safety data and high cost. With an announced WAC price of $6,900/year for erenumab, ICER estimates an annual cost of $5,000/year after discounts. ICER stated that a price of $3,700 to $5,300 per year to be cost effective. Erenumab or fremanezumab were found to be cost effective in QALY gained in patients that had failed at least one preventative therapy.
Stay current with developments for drugs to reduce monthly migraines and all drugs in the late stages of development with the Prescribe Right Pharmaceutical Pipeline Tracker.
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