Emgality Receives FDA Approval for the Preventive Treatment of Migraine

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults. Emgality offers a once-monthly, self-administered, subcutaneous injection. Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Emgality will be available to patients shortly after approval. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program. Emgality will be available for pickup at retail pharmacies.

Migraine is a disabling, neurologic disease that affects more than 30 million American adults. According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56 billion annually, yet migraine remains under-recognized and under-treated.

"Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment," said Christi Shaw, president, Lilly Bio-Medicines. "For more than two decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease."

The efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN).

EVOLVE-1 and EVOLVE-2 were six-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic migraine (defined as 4-14 migraine headache days [MHDs] per month). REGAIN was a three-month, double-blind, placebo-controlled study that enrolled adult patients with chronic migraine (defined as at least 15 headache days per month with at least 8 MHDs per month). In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat study population.

EVOLVE-1 (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.2, placebo 9.1)

   · Mean change from baseline (days): -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo (p<0.001)

   · At least a 50 percent reduction in MHDs in any given month on average (% responders): 62% (N=210) for Emgality 120 mg compared to 39% (N=425) for placebo (p<0.001)

   · At least a 75 percent reduction in MHDs in any given month on average (% responders): 39% (N=210) for Emgality 120 mg compared to 19% (N=425) for placebo (p<0.001)

   · 100 percent reduction in MHDs in any given month on average (% responders): 16% (N=210) for Emgality 120 mg compared to 6% (N=425) for placebo (p<0.001)

EVOLVE-2 (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.1, placebo 9.2)

   · Mean change from baseline (days): -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo (p<0.001)

   · At least a 50 percent reduction in MHDs in any given month on average (% responders): 59% (N=226) for Emgality 120 mg compared to 36% (N=450) for placebo (p<0.001)

   · At least a 75 percent reduction in MHDs in any given month on average (% responders): 34% (N=226) for Emgality 120 mg compared to 18% (N=450) for placebo (p<0.001)

   · 100 percent reduction in MHDs in any given month on average (% responders): 12% (N=226) for Emgality 120 mg compared to 6% (N=450) for placebo (p<0.001)

REGAIN (Over Months 1 to 3 - baseline migraine headache days: Emgality 19.4, placebo 19.6)

   · Mean change from baseline (days): -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo (p<0.001)

   · At least a 50 percent reduction in MHDs in any given month on average (% responders): 28% (N=273) for Emgality 120 mg compared to 15% (N=538) for placebo (p<0.001)

   · Emgality 120 mg was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly MHDs over the three-month treatment period.

The recommended dose for Emgality is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.

The safety of Emgality was evaluated in three clinical trials that included more than 2,500 patients.

Hypersensitivity reactions (e.g., rash, urticaria and dyspnea) have been reported with Emgality in clinical studies, can occur days after administration and may be prolonged. The most common adverse reactions (incidence ≥2% for Emgality and at least 2% greater than placebo) associated with Emgality treatment (120 mg vs. placebo) were injection site reactions (18% vs. 13%). See additional Important Safety Information below.

"We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible," said Shaw. "Lilly's choice to provide Emgality for up to 12 months free to all eligible patients with commercial insurance underscores our 25-year commitment to recognizing and addressing the need experienced by those with migraine."

"I have lived with migraine for more than 30 years, and I have experienced firsthand the impact it has on your life, including the ability to perform daily activities," said Jill Dehlin, chair, Patient Leadership Council, National Headache Foundation. "Those of us living with migraine have spent years hoping for new treatment options, and I am thankful for the efforts by researchers, investigators and clinical trial patients who have helped make this possible."

On September 21, 2018, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Emgality for the prophylaxis of migraine in adults who have at least four migraine days per month. The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union.

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.