Acromegaly treatment’s supply suspended as Novartis hands over sales rights – Korea Biomedical Review

Koreans with acromegaly will likely experience more difficulties as they lose one of the two available second-line treatments.

According to industry sources, the supply of Signifor Lar, an acromegaly treatment, has recently stopped. The halt in supply comes after Novartis, the original developer of the drug, transferred the sales rights of the drug to Recordati SpA, an Italian pharmaceutical company.

Novartis supplied the drug in the Korean market through Samoh Pharmaceutical, a local pharmaceutical company.

Signifor Lar started receiving insurance benefits in November 2017 as a second-line treatment for acromegaly. At the time, Signifor Lar was the only second-line treatment option. However, the government expanded treatment options for patients by deciding to reimburse Somavert, an acromegaly treatment developed by Pfizer, in September.

Acromegaly is a rare disease that occurs as a tumor in the pituitary gland and causes facial deformities and enlarged hands and feet due to excessive growth hormone secretion.

The main treatment goal for acromegaly is to decrease growth hormone secretion and insulin-like growth factor-1. Unfortunately, about 45 percent of patients have uncontrolled biochemical levels despite first-line treatments requiring them to take either Signifor Lar or Somavert.

Since it is a rare disease, industry experts say that only about 10 patients take Signipo Lar.

However, if patients change their drug to Somarvert, they may not receive insurance benefits due to the ambiguous reimbursement standards. It is also difficult for the patients to go back to the first-line treatments as they have already failed to see efficacy for such treatments.

In a phase 3 study, Signipo Lar demonstrated superiority in evaluating biochemical control, GH and IGF-1 control, and tumor size reduction compared with a maximum dose of a first-generation somatostatin analog.

As a result of the study, the proportion of patients who achieved biochemical control, the primary efficacy evaluation index, at week 24 was 15 percent in the Signiforar 40mg group and 20 percent in the 60mg group, higher than the somatostatin analog group.

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Acromegaly treatment's supply suspended as Novartis hands over sales rights - Korea Biomedical Review