(Reuters) – French drugmaker Sanofi’s new Toujeo diabetes drug has been recommended for approval in Europe, two days after being cleared for sale in the United States, regulators said on Friday.
The positive decision from experts at the European Medicines Agency (EMA) had been expected and paves the way for the long-lasting insulin product to be marketed soon in Sanofi’s chosen first European markets, Germany and Britain.
Recommendations for marketing approval by the agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
Significantly, the EMA highlighted the benefits of Toujeo in reducing the risk of hypoglycemia, or dangerously low blood sugar levels, compared to Lantus
”In Type 2 diabetes patients, the incidence of confirmed hypoglycemia was lower with Toujeo, in particular at night, as compared to insulin glargine 100 U/ml (Lantus),” the agency said in a statement.
That endorsement contrasts with the medicine’s U.S. label, which disappointed many investors by failing to highlight lower rates of hypoglycemia.
However, the EMA also noted a 10-18 percent higher Toujeo dose may be needed to achieve target ranges for blood sugar levels.
Toujeo is a follow-up to Sanofi’s top-selling Lantus drug, which accounts for a fifth of the company’s sales. Sanofi hopes to convert patients to Toujeo as Lantus faces loss of patient protection.
A key issue in determining its take-up will be the price Sanofi charges.
Sanofi has declined to detail the cost before Toujeo is launched, although it has stated that ”pricing will not be a barrier to access”.
While some analysts have suggested Toujeo will need to be priced at a discount to Lantus to ensure strong take-up, Tim Anderson of Bernstein said industry contacts had indicated it was likely to be priced at parity, although Sanofi could still offer rebates to bring the net cost down.
Toujeo has the same active ingredient as Lantus, insulin glargine, but at three times the concentration and with a design to release the insulin more gradually.
Lantus is the world’s most prescribed insulin with sales of 6.34 billion euros ($7.12 billion) in 2014.
From www.reutershealth.com
Nyhetsinfo
www red DiabetologNytt
