Merck and Pfizer Enter an Agreement to Develop an SGLT-2 Inhibitor, Ertugliflozin
On April 29, Merck and Pfizer announced that they are entering a partnership to develop ertugliflozin for type 2 diabetes. Ertugliflozin is a sodium-glucose linked transporter-2 (SGLT-2) inhibitor that comes in a once-daily pill. Originally, Pfizer was developing and testing ertugliflozin as a drug to be taken alone. However, this partnership will allow the companies to also develop ertugliflozin combination pills: ertugliflozin plus Merck’s DPP-4 inhibitor Januvia (sitagliptin) and ertugliflozin plus Januvia and metformin. These combinations should make taking medication much easier, since they will reduce the number of pills from two or three to one.
Currently, ertugliflozin has finished its phase 2 trials and is ready to begin phase 3 trials. In phase 2, ertugliflozin reduced A1c by an average of 0.8%, weight by 5.5 pounds, and blood pressure by about 4 mmHg. As we’ve noted in previous articles on SGLT-2 inhibitors, the drugs also work in a glycemic-dependent fashion, meaning there is a very low risk of hypoglycemia. Since ertugliflozin is still in development, safety data is still pending from larger phase 3 studies. We’ll be especially interested to see the risk of genital infections, a common side effect of other drugs in this class. Please see our learning curve on SGLT-2 inhibitors to learn more.
As a reminder, the FDA approved Janssen’s Invokana (canagliflozin) at the end of March. Invokana is the first drug in the SGLT-2 inhibitor class, although others, such as ertugliflozin and Lilly and Boehringer Ingelheim’s empagliflozin, which was recently submitted to the FDA, may soon join Invokana. Forxiga (dapagliflozin) is available in the EU, and Bristol-Meyers Squibb and AstraZeneca plan to reapply for FDA approval in mid-2013. Additionally, Lexicon is developing an SGLT-1/SGLT-2 inhibitor for treating type 1 diabetes, LX4211.–MN
