MSD and Pfizer receive approval for combo diabetes therapy
MSD (known as Merck in North America) and Pfizer have announced that their sodium-glucose co-transporter 2 (SGLT2) inhibitor has received approval by the FDA, for use as a single therapy or as a fixed-dose combination therapy.
The combination therapy will be alongside MSD’s existing blockbuster type 2 diabetes drug, Januvia. The approval will allow MSD to offer Steglatro, as the treatment is known, to compete against a raft of similar SGLT2 inhibitors, such as AstraZeneca’s Farxiga, Eli Lilly and Boehringer Ingelheim’s Jardiance, and Johnson & Johnson’s Invokana.
The approval was based on data from Phase 3 trials announced back in June, which met its primary endpoint at 26 weeks by showing a reduction in HbA1c from baseline of 0.7% (95% CI -0.9% to -0.5%) and 0.8% (95% CI -0.9% to -0.6%).
“These results, combined with findings from other studies in the VERTIS program, underscore the potential of ertugliflozin as an important therapeutic option for adults with type 2 diabetes to help improve their glycemic control,” commented James Rusnak, Senior Vice President and Chief Development Officer, Internal Medicine, Pfizer Global Product Development, at the time results were released.
Steglatro works by encouraging the body to remove excess glucose through urine, adding to the efficacy of established treatments on the market.
For this, MSD already possesses Januvia – a treatment that brought in $6.11 billion last year, though these sales are now threatened by increased competition.
However, the diabetes area is changing rapidly again, as the field now pivots towards showing that treatments are able to reduce the risk of cardiovascular events.
AstraZeneca, for instance, already has studies regarding cardiovascular safety underway and will post the results sometime in 2019. While Lilly/BI’s Jardiance became the first treatment that was able to display a reduction in heart-related deaths on its label.
Pfizer and MSD’s Steglatro are expected to hit annual sales of greater than $1 billion.
Pfizer has announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee …
Valneva and Pfizer have announced positive paediatric and adolescent immunogenicity and safety data for their …