|Generic Name||Brand Name||Dosage Form||Company||Ticker||FDA Approved Indications||Approval|
|Eptinezumab||Vyepti||Intravenous Injection||Lundbeck||HLUYY||Preventive treatment of migraine in adults||Full|
|Erenumab||Aimovig||Subcutaneous Injection||Amgen||AMGN||Preventive treatment of migraine in adults||Full|
|Fremanezumab||Ajovy||Subcutaneous Injection||Teva Pharmaceuticals||TEVA||Preventive treatment of migraine in adults||Full|
|Galcanezumab||Emgality||Subcutaneous Injection||Eli Lilly||LLY||Preventive treatment of migraine in adults||Full|
|Galcanezumab||Emgality||Subcutaneous Injection||Eli Lilly||LLY||Treatment of episodic cluster headache in adults||Full|
|Rimegepant||Nurtec||Orally disintegrating tablets||Biohaven Pharmaceuticals||BHVN||Acute treatment of migraine with or without aura in adults||Full|
|Ubrogepant||Ubrelvy||Oral Tablet||Allergan||AGN||Acute treatment of migraine with or without aura in adults||Full|
The FDA’s Accelerated Approval program aims to promote earlier approval of drugs to fill an unmet medical need. As such, approval is based on a surrogate endpoint (laboratory measurement, tumor shrinkage, physical sign) that is thought to predict a clinical benefit. Use of surrogate endpoint(s) results in a shorter time in development prior to FDA approval.
If a company receives accelerated approval, they are still required to conduct an additional study to confirm the assumed clinical benefit. If the confirmatory trial shows a clinical benefit, then the FDA will grant traditional (“full”) approval. If the confirmatory trial does not show a clinical benefit, the FDA may elect to remove the drug from the market.