FDA shoots down Merck's bid to expand Januvia label

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• The Food and Drug Administration has rejected Merck's attempt to include data from a cardiovascular outcomes study on the label for its diabetes drug Januvia (sitagliptin), the pharma announced April 7.

• Merck said it had received a complete response letter from the regulator regarding its supplemental new drug application for Januvia and the sister medicine Janumet (sitagliptin/metformin).

• The pharma had sought to add the results from its TECOS outcomes trial to prescribing information for sitagliptin-containing drugs. That study had read out positively in 2015, demonstrating Januvia didn't increase the risk of a cardiovascular event compared to standard of care.

Taken together, Januvia and Janumet are Merck's top-selling drug franchise, pulling in $6.1 billion in worldwide sales last year. While pricing pressures in the U.S. diabetes market have impacted all players in the space, Merck saw strong volume growth in the U.S. and EU last year.

Rejection of Merck's attempt to include CV outcomes data on Januvia and Janumet's labels could hurt future growth prospects, taking away a potential competitive advantage for the DPP-4 inhibitors (for now, at least). This attempt came after competitors in another area of the diabetes market — namely the SGLT-2 inhibitor by Eli Lilly and Boehringer Ingelheim — showed it reduced the risk of cardiovascular death. The addition of the claim to the Jardiance (empagliflozin) label was a major differentiator for the entire class.

While the rejection is a setback, it shouldn't hit Merck too hard. The Januvia franchise has a strong position in the DPP-4 market (and the diabetes market as a whole), and the big pharma has submitted a combination of its experimental SGLT-2 inhibitor ertugliflozin with Januvia for approval to the FDA and the EMA. A decision from the U.S. regulator is expected by year end.

That combo could help Merck extend the lifecycle of the Januvia franchise and compete with other diabetes drugmakers with existing SGLT-2 franchises, such as Lilly, AstraZeneca and Johnson & Johnson.

Merck said it was reviewing the FDA's complete response letter and would discuss "next steps" with the agency.

• Press release Merck

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