Sanofi is One Step Closer to Challenging Blockbuster Diabetes Sales from its Rival
The US Food and Drug Administration (FDA) has approved Sanofi-Aventis’ short-acting insulin Admelog (insulin lispro injection) for improved control of blood sugar levels in people suffering from diabetes mellitus. Admelog is indicated for type 1 diabetes mellitus patients aged three years and above, and to treat adults with type 2 diabetes mellitus. Its dosing will depend on the administration route, individual metabolic needs, blood glucose monitoring results and glycaemic control goal. The drug can be administered through subcutaneous injection or infusion, or by intravenous infusion.
Sanofi-Aventis submitted an application that was partially based on the FDA’s safety and effectiveness findings for Humalog (insulin lispro injection).
The application also included Admelog-specific data from two Phase III clinical trials conducted in about 500 patients to validate the product’s safety and efficacy for approved uses.During the trials, the most common Admelog-related adverse reactions were found to be hypoglycaemia, itching, and rash.
FDA Commissioner Scott Gottlieb said: “One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives.
“This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease.In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand-name drugs approved through the agency’s abbreviated pathways.” Gottlieb added.
According to FiercePharma, Admelog is expected to find a ready market once it launches. A Barclays survey this year found that 42% of respondents expect to write scripts for the medication once it arrives, versus just 10% who thought they’d prescribe Basaglar. One reason is that the rapid-acting insulin market is far more concentrated, with Humalog and Novo Nordisk’s NovoLog holding most of the market.
As competition in diabetes has ratcheted up in recent years, both drugmakers—and fellow diabetes drug maker Novo Nordisk—have seen sales suffer and resorted to job cuts to offset challenges. Lilly recently embarked on a round of 3,500 layoffs as it looks to cut costs. Sanofi led Big Pharma in job reductions for 2016, according to EP Vantage, while Novo Nordisk chopped 1,000 positions in September 2016
The new approval—which came under an abbreviated regulatory pathway—comes amid a push at the FDA to bolster competition in the market as a way of lowering drug costs. Shortly after taking the position, Scott Gottlieb, made that one of his goals.
“In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand-name drugs approved through the agency’s abbreviated pathways,” Gottlieb said in a statement on Monday.