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Takeda Treads Carefully With DPP-4 Late-Arrival Nesina, Plans Summer Launch

 
• By Emily Hayes

Takeda’s beleaguered Nesina (alogliptin) becomes the fourth DPP-4 inhibitor approved by FDA for diabetes; it remains to be seen whether the drug can find its place in a highly competitive space that continues to be controlled by Merck’s first-to-market blockbuster Januvia.

Takeda Pharmaceutical Co. Ltd. finally won FDA approval for its DPP-4 inhibitor Nesina (alogliptin) along with clearance of two fixed-dose combinations after a painfully protracted regulatory process, but the company says it will be taking still more time to carefully plan a large-scale commercial launch of the three drugs in the summer.

In addition to single-agent Nesina, Oseni, a combination of alogliptin and the company’s blockbuster diabetes drug Actos (pioglitazone), which recently lost patent protection in the U.S., and Kazano (alogliptin/metformin) were approved on Jan. 25

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More from Approvals

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

More from Product Reviews

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.