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Novartis Korea launches 2nd generation acromegaly therapy
  • By Marian Chu
  • Published 2018.05.31 17:48
  • Updated 2018.05.31 17:48
  • comments 0
Signifor LAR (pasireotide pamoate)
Source: Korea Pharmaceutical Information Center

Novartis Korea Thursday launched Signifor LAR (long-acting release)(ingredient: pasireotide pamoate), an acromegaly therapy, on the domestic market.

Acromegaly is a rare disease where parts of the body such as hands, feet, and face grow excessively, leading to facial deformity or limb enlargement. It is often caused by a pituitary adenoma, a benign tumor that makes too much of a growth hormone.

Signifor LAR, as a 2nd generation somatostatin analog (SSA), was approved in Korea in December 2016 to treat acromegaly patients who could not get or benefit from surgery and those who did not benefit from other SSAs.

The therapy will be available in 20 mg, 40 mg, and 60 mg doses and is administered intramuscularly once every four weeks, Novartis Korea said.

Under reimbursement, Signifor LAR fetches 1,165,657 won ($1,084) per 20 mg vial, 1,805,220 won per 40 mg vial, and 2,243,889 won per 60 mg vial.

Acromegaly patients who have more than 1.3 times the maximum of the normal range of insulin-like growth factor 1 (IGF-1) and an average growth hormone (GH) value above 2.5 mg/L despite administration of an existing SSA within the past 24 weeks can benefit from the reimbursement.

“Sigifonar is the only treatment alternative for patients who have not responded well to first-generation therapy,” said Christoph Lorez, general manager of Novartis Oncology Korea. “Novartis will continue to work on developing rare disease treatments to ensure that a small number of patients are not alienated from treatment benefits.”

Around 45 percent of patients treated with first-generation SSAs have unregulated biochemical values, according to Novartis Korea.

The company said the drug proved efficacy and safety in a multicenter, randomized, phase 3 PAOLA trial that divided 198 patients into a pasireotide 40 mg, pasireotide 60 mg, and an active control group that used the first generation SSA.

Findings showed that 10 patients in the 40 mg group and 13 patients in the 60 mg group achieved biochemical control while none in the active control group did so.

Findings also showed 25 percent in the Signifor LAR group, and 26 percent in the 60 mg group had achieved normalized IGF-1 values while not in the active control group did.

Meanwhile, 35 percent of the 40-mg group had controlled GH values under 2.5㎍/L, 43 percent in the 60 mg, and 13 percent in the control group. Around 19 percent in the 40 mg and 11 percent in the 60 mg group had their tumors decreased by more than 25 percent, while 2 percent in the control group did.

The most common adverse events of Signifor LAR were hyperglycaemia, diabetes, and diarrhea.

yjc@docdocdoc.co.kr

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