• Positive opinion based on a clinical development program including more than 600 people with type 1 or type 2 diabetes
PARIS, France I May 04, 2020 I Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Insulin aspart Sanofi® (insulin aspart 100 Units/mL). CHMP recommended the use of Insulin aspart Sanofi to treat adults, adolescents and children aged 1 year and above who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.
This positive opinion is the first regulatory milestone in the EU for any biosimilar insulin aspart product. Sanofi already has two rapid-acting insulin analogs approved by European regulators.
“Insulin aspart is an important and widely-used treatment for people with diabetes who require rapid control of their blood sugar at mealtime,” said Sandra Silvestri MD, PhD, Global Head of Medical, Sanofi General Medicines. “Our development of this investigational biosimilar product reflects Sanofi’s expertise and heritage in developing and manufacturing insulins for people with type 1 or type 2 diabetes and their physicians.”
The recommendation is based on a clinical development program involving more than 600 adults with type 1 or type 2 diabetes. This program comprised a pharmacokinetic / pharmacodynamic (PK/PD) Phase 1 study to evaluate the product’s similarity in exposure and activity1 and a multi-center Phase 3a clinical trial (Gemelli 12) evaluating its safety and efficacy. Each study compared the investigational product to insulin aspart 100 Units/mL as currently approved for use by adults with type 1 or type 2 diabetes in the U.S. and EU.
“We welcome the CHMP positive opinion for Insulin aspart Sanofi and look forward to the final decision of the European Commission (EC),” said Cyril Grandchamp- Desraux, Global Head of Diabetes, Sanofi General Medicines. “By broadening our range of biosimilar rapid-acting insulins within our quality insulin portfolio, we continue to acknowledge our commitment to expand the affordability and sustainability of insulin treatments.”
The European Commission is expected to make a final decision on marketing authorization for Insulin aspart Sanofi in the coming months.
References
1. Kapitza, et al. “Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes.” Diabetes technology & therapeutics 2020 Apr;22(4):278-284. doi: 10.1089/dia.2019.0351.
2. Garg, SK et al. “Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1).” Diabetes technology & therapeutics 2020 Feb;22(2):85-95. doi: 10.1089/dia.2019.0382.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
SOURCE: Sanofi
Post Views: 68
• Positive opinion based on a clinical development program including more than 600 people with type 1 or type 2 diabetes
PARIS, France I May 04, 2020 I Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Insulin aspart Sanofi® (insulin aspart 100 Units/mL). CHMP recommended the use of Insulin aspart Sanofi to treat adults, adolescents and children aged 1 year and above who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.
This positive opinion is the first regulatory milestone in the EU for any biosimilar insulin aspart product. Sanofi already has two rapid-acting insulin analogs approved by European regulators.
“Insulin aspart is an important and widely-used treatment for people with diabetes who require rapid control of their blood sugar at mealtime,” said Sandra Silvestri MD, PhD, Global Head of Medical, Sanofi General Medicines. “Our development of this investigational biosimilar product reflects Sanofi’s expertise and heritage in developing and manufacturing insulins for people with type 1 or type 2 diabetes and their physicians.”
The recommendation is based on a clinical development program involving more than 600 adults with type 1 or type 2 diabetes. This program comprised a pharmacokinetic / pharmacodynamic (PK/PD) Phase 1 study to evaluate the product’s similarity in exposure and activity1 and a multi-center Phase 3a clinical trial (Gemelli 12) evaluating its safety and efficacy. Each study compared the investigational product to insulin aspart 100 Units/mL as currently approved for use by adults with type 1 or type 2 diabetes in the U.S. and EU.
“We welcome the CHMP positive opinion for Insulin aspart Sanofi and look forward to the final decision of the European Commission (EC),” said Cyril Grandchamp- Desraux, Global Head of Diabetes, Sanofi General Medicines. “By broadening our range of biosimilar rapid-acting insulins within our quality insulin portfolio, we continue to acknowledge our commitment to expand the affordability and sustainability of insulin treatments.”
The European Commission is expected to make a final decision on marketing authorization for Insulin aspart Sanofi in the coming months.
References
1. Kapitza, et al. “Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes.” Diabetes technology & therapeutics 2020 Apr;22(4):278-284. doi: 10.1089/dia.2019.0351.
2. Garg, SK et al. “Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1).” Diabetes technology & therapeutics 2020 Feb;22(2):85-95. doi: 10.1089/dia.2019.0382.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
SOURCE: Sanofi
Post Views: 68
