Tags : Migraine

Insights+

Insights+: Novel Approvals of February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health care The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan […]Read More

Biotech Regulatory

Lundbeck’s Vyepti (eptinezumab-jjmr) Receives the US FDA’s Approval to Prevent

Shots: The approval is based on two P-IIItrials PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine  involves assessing of Vyepti (100mg or 300mg) vsPBO in 2076 patients with migraine PROMISE 1 study results: mean migraine frequency ~8.6 migraine days/month, mean change in MMD in 1-3mos. @100mg or 300mg  (-3.9 days, -4.3 days vs -3.2 […]Read More

Pharma

Eli Lilly Launches Reyvow (lasmiditan) C-V for the Treatment of

Shots: Eli Lilly launches Reyvow C-V 50/100/200mg, indicated for the acute treatment of migraine with/without aura & will be available in US pharmacies in the next few days The efficacy of the therapy is evaluated in SAMURAI and SPARTAN studies assessing Reyvow vs PBO in 4439 patients with migraine, results demonstrated that patients achieved fast […]Read More