Daiichi Sankyo receives Japanese marketing approval for two drugs

Daiichi Sankyo has obtained marketing approval in Japan for its minnebro and tarlige tablets to treat hypertension and peripheral neuropathic pain (PNP) respectively.

Minnebro was identified during a partnership with US-based drug discovery company Exelixis and was then developed by Daiichi Sankyo.

The approval is based on data from Phase III clinical studies, including ESAX-HTN trial that compared the safety and efficacy of the drug with eplerenone in Japanese essential hypertension patients.

Minnebro is being further evaluated by Daiichi Sankyo in a separate Phase III trial involving patients suffering from diabetic nephropathy in Japan.

The collaboration will see with Daiichi Sankyo pay Exelixis $20m in milestone payment upon the first commercial sale of the drug in Japan.

Exelixis president and CEO Michael Morrissey said: "The approval of minnebro brings an important new therapeutic option to clinicians in Japan.

"As partnered compounds like Minnebro are commercialised, we are committed to using resulting collaboration revenues to reinvest in our business, build our pipeline, and pursue long-term, sustainable growth."

The approval granted for tarlige comes after a review of data from a Phase III trial in diabetic peripheral neuropathic pain (DPNP) patients and another study in subjects with postherpetic neuralgia (PHN).

Tarlige is an Alpha₂delta ligand that binds to the respective subunits of voltage-dependent calcium channels.

Daiichi Sankyo and UCB Japan have received approval for the expanded indication of vimpat tablets. This adds a new dosage and administration regimen for paediatric epilepsy patients with partial onset seizures with or without secondary generalisation.

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