Signifor Lar discontinued in the lacking acromegaly Tx mkt

Supply of Signifor Lar discontinued in the domestic acromegaly market that already lacks treatment options

One second-line treatment option in acromegaly leaves market… no other option but Somavert remains

Novartis sells Signifor's rights to Recordati… Samoh Pharm’s distribution agreement cancelled

A considerable blow is expected in the already lacking acromegaly treatment market with the discontinuation of one of its very few available options.

 

According to industry sources, the domestic supply of the acromegaly treatment ‘Signifor LAR (pasireotide)’ has been discontinued.

 

The decision was made as Novartis sold the rights to Signifor La to Recordati SpA.,an Italian pharmaceutical company.

 

As a result, the drug that had been developed by Novartis and distributed by Samoh Pharm will now be discontinued in Korea.

 

However, the problem lies in the patients.

 

Signifor LAR is a second-line treatment for acromegaly that was listed for reimbursement in November 2017.

 

At the time, Signifor LAR was the only second-line treatment option available in the market.

 

However, Pfizer’s ‘Somavert (pegvisomant)’ was listed in September, adding one more option as a second-line treatment.

 

The discontinuation in its supply would most greatly affect those who are currently receiving Signifor LAR.

 

As a rare disease treatment, around 10 patients in Korea have been using Signifor LAR, but they may experience insurance cuts if they switch to Somavert due to unclear reimbursement standards.

 

And the patients cannot return to the drugs that they had used for first-line treatment after already failing treatment with the same drugs.

 

Also, there are only two options available in the first-line – Ipsen’s ‘Somatuline Autogel (lanreotide acetate)’ and Novartis’ ‘Sandostatin LAR (octreotide).’ Acromegaly is a rare disease in which the pituitary tumor causes hypersecretion of growth hormones to result in facial deformation and hypertrophy of the hands and feet.

 

The key treatment objective for acromegaly is to reduce the level of growth hormones and insulin-like growth factor-1 (IGF-1) secretion.

 

However, 45% of the patients who were treated with first-generation somatostatin analog (SSA) were unable to achieve biochemical control.

 

Meanwhile, in a Phase III trial that compared Signifor LAR with a maximum dose first-generation SSA, Signifor LAR demonstrated superiority in ▲ Biochemical control (mean GH level under 2.5㎍/L and normal range IGF-1 level) ▲GH and IGF-1 control ▲decrease n tumor size Patients whose acromegaly was not adequately controlled after being treated for over 6 months existing SSA (octreotide 30mg or lanreotide 120mg) participated in the trial and were randomly assigned to Signifor LAR 40mg, 60mg, or first-generation SSA for treatment.

 

Study results showed that the proportion of patients that met the primary endpoint of biochemical control at 24 weeks was 15% for the Signifor LAR 40mg group and 20% for the Signifor LAR 60mg group, which was higher than that of the control group (0%).