In medically naïve patients... SIGNIFOR LAR DEMONSTRATED SUPERIOR EFFICACY OVER OCTREOTIDE LAR

SIGNIFOR LAR was directly compared with Octreotide LAR²⁴

A prospective, multicenter, double-blind, randomized, parallel-group, phase 3 study in adults with active acromegaly defined by elevated GH and IGF-1 levels* in medically naïve patients.²⁴

Study Design: A multicenter, randomized, double-blind study was conducted to assess the safety and efficacy of SIGNIFOR LAR in drug-naïve patients with active acromegaly. A total of 358 patients naïve to drugs used to treat acromegaly were randomized in a 1:1 ratio to SIGNIFOR LAR or octreotide LAR. Randomization was stratified based on previous pituitary surgical status (eg, at least 1 prior pituitary surgery versus no prior pituitary surgery).

*As confirmed by a 2-hour five-point mean GH level >5 μg/L or lack of suppression of GH nadir to <1 μg/L after an OGTT and elevated IGF-1 for age and sex-matched controls.
†De novo patients with a pituitary adenoma visible on MRI but who refused pituitary surgery or for whom surgery was contraindicated were also eligible.
‡Stratified into two groups: 1) after pituitary surgery or 2) de novo. A dose increase to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, at month 3 or 7 based on biochemical response (mean GH ≥2.5 g/L and/or IGF-1 above the ULN).

SIGNIFOR LAR demonstrated superior efficacy over octreotide LAR

Significantly more medically naïve patients achieved biochemical control^§ with SIGNIFOR LAR (P<0.01)^3,24

• 31.3% of patients receiving SIGNIFOR LAR (n=176) achieved biochemical control compared with 19.2% of those on octreotide LAR (n=182) overall

• The primary endpoint was biochemical control defined as a GH level less than 2.5 ug/L and an IGF-1 level that was normal for the patient’s sex and age
• Significantly more patients treated with SIGNIFOR LAR achieved biochemical control than those treated with octreotide LAR
• While the study was not powered to detect treatment differences between subgroups, there was an increased response in patients who had previously undergone surgery

§Biochemical control defined as achieving GH <2.5 μg/L and normal IGF-1 for age and sex at month 12.²⁴

Adverse events documented in medically naïve patients

llDiabetes mellitus includes the terms diabetes mellitus and type 2 diabetes mellitus.
¶Sinus bradycardia includes the following PTs: bradycardia and sinus bradycardia.
SEE SECTION 6.1 IN FULL PRESCRIBING INFORMATION FOR COMPLETE ADVERSE REACTION TABLE.