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news.Takeda Pharmaceutical has filed applications to the Japanese Ministry of Health, Labour and Welfare (MHLW) to change the dosage and administration of its agents used in the treatment of central precocious puberty (CPP), namely, Leuplin for injection 1.88 and Leuplin for injection 3.75 (generic name: leuprorelin acetate).
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Takeda Pharma said that Leuplin was approved for CPP treatment in 1994, with a maximum allowable dosage of 90µg/kg/4 weeks.
The MHLW requested Takeda to modify Leuplin’s dosage and administration with respect to the maximum allowable dosage for CPP treatment, following the results of discussions by the Review Committee on Unapproved Drugs and Indications with High Medical Needs (Review Committee) held on 27 April 2010.
In a subsequent meeting held on 10 November, the review committee determined that such a supplemental application was eligible for submission based on evidence already in the public domain.
On 24 November committee on Drug I, Pharmaceutical Affairs and Food Sanitation Council (PAFSC) concluded that an application based on such evidence could be allowed.
Accordingly, Takeda has filed applications based on evidence that already exist in the public domain.