Ipsen Announces NMPA Approval of Lanreotide Acetate Sustained-Release Injection (Pre-filled Syringe) for Acromegaly in China

Beijing, December 24, 2019 /PRNewswire/ --Ipsen, a global leader in biopharmaceuticals, announced today in China thatThe National Medical Products Administration (NMPA) of China has approved lanreotide acetate sustained-release injection (prefilled syringe) for the treatment of acromegaly in patients whose blood growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels remain abnormal after surgery and/or radiotherapy, or for those who are not candidates for surgical and/or radiotherapeutic intervention. Lanreotide acetate sustained-release injection (prefilled syringe) is registered and marketed in approximately 70 countries worldwide and is one of the sustained-release somatostatin analogs (SSAs) recommended by multiple domestic and international guidelines and consensus statements.^{[4]、[5]、[6]}。

Chen Jialin, General Manager of Ipsen China, stated, “Ipsen is committed to providing advanced treatment solutions for patients in China within the field of rare diseases. We have a deep understanding of the unmet treatment needs of patients with acromegaly and hope to bring more new therapeutic options to clinicians and patients, helping more patients improve their quality of life. At the same time, we appreciate the government’s promotion of policies for rare diseases. In the next 3–5 years, we will strive to accelerate the introduction of more innovative products for rare and even ultra-rare diseases into China. Guided by the principle of patient-centricity, we will spare no effort to collaborate with all stakeholders in addressing the challenges of rare diseases in China, so that patients suffering from these conditions no longer have to wait in hopelessness.”

Acromegaly Seriously Threatens Patients' Life and Health

Acromegaly, abbreviated as “acromegaly,” is a chronic, progressive endocrine disorder with an insidious onset; by the time patients seek medical attention, the disease course may have lasted for several years or even more than 10 years.^[7]。

The incidence and diagnosis rates of acromegaly are low. More than 95% of acromegaly cases are caused by growth hormone (GH)-secreting pituitary adenomas.^[8]. Clinical manifestations in patients with acromegaly include characteristic physical features such as enlarged hands and feet, macrorhinia, thickened lips, and prognathism; symptoms resulting from pituitary adenoma compression, such as headache, decreased visual acuity, visual field defects, and hypopituitarism; cardiovascular and cerebrovascular involvement, including hypertension, coronary heart disease, myocardial hypertrophy, and cardiac dysfunction; respiratory system involvement, such as snoring, ventilatory impairment, and sleep apnea; impaired glucose tolerance and diabetes mellitus; and osteoarticular involvement. Patients with acromegaly may also have an increased risk of colon polyps, colorectal cancer, thyroid cancer, and lung cancer.^[9]，Cardiovascular complications are the most common cause of death.^[10]。

The occurrence of complications in acromegaly can severely impact patients' quality of life and lifespan. The physical damage caused by the disease may lead to a significant decline in quality of life and shortened life expectancy. Disfigurement may result in psychological issues; suffering from complications can impair normal work function and even lead to family breakdown. Many patients are unable to receive standardized treatment due to financial constraints, resulting in gradual disease progression. Complications are common among patients with acromegaly, which also increases healthcare resource utilization and medical costs.

Pre-filled Syringes, Flexible Treatment Regimen Adjustment

The newly approved lanreotide acetate sustained-release injection (pre-filled syringe) represents a technological innovation, being the first ready-to-use sustained-release formulation based on self-assembling nanotube technology.^[11]. Currently, the product is available in three strengths: 60 mg, 90 mg, and 120 mg. Study data indicate that patients with well-controlled biochemical parameters can be administered the drug at a 120 mg dose with extended injection intervals of every 6 or 8 weeks.^[12]。

Professor Wang Haijun, Director of the Department of Neurosurgery and Director of the Pituitary Tumor Diagnosis and Treatment Center at The First Affiliated Hospital of Sun Yat-sen University, stated, “As a rare yet insidiously progressive disease that poses a serious threat to public health, acromegaly requires long-term treatment and follow-up through collaborative efforts between clinicians and patients. Studies have shown that the mortality rate among patients with acromegaly is 1.3–1.9 times that of their age-matched peers.”^{[13]、[14]、[15]}Surgical treatment is currently the preferred therapeutic option, with an overall cure rate of approximately 65%.^[9]。“If postoperative biochemical remission is not achieved, patients require comprehensive treatment, including pharmacological and radiotherapeutic interventions. A variety of medications can be selected, such as lanreotide acetate prolonged-release injection, with treatment regimens tailored to individual patient circumstances. Meanwhile, we call on all sectors of society to heighten awareness of acromegaly, promote earlier diagnosis, strengthen long-term follow-up practices, and facilitate the widespread adoption of standardized diagnostic and therapeutic protocols, thereby improving the quality of life for patients with acromegaly and supporting their timely recovery.”

[1] Package Insert for Lanreotide Acetate Sustained-Release Injection (Pre-filled Syringe)

[2] Pouget E et al. J Am Chem Soc. 2010; 132:4230-41.

[3] WORLDWIDE-MARKETING-STATUS-FOR-PSURs

[4] AACE clinical practice guideline: Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-2014.

[5] Melmed S, Bronstein MD, Chanson P, et al. A Consensus Statement on acromegaly therapeutic outcomes. Nat Rev Endocrinol. 2018 Sep;14(9):552-561.

[6] Acromegaly Consensus Group consensus statement: Giustina A, Chanson P, Kleinberg D, et al. A consensus on the medical treatment of acromegaly. Nat Rev Endocrinol. 2014;10:243-248

[7] Chinese Society of Neurosurgery, Chinese Pituitary Adenoma Collaborative Group, Chinese Society of Endocrinology. Guidelines for the Diagnosis and Treatment of Acromegaly in China (2013). Chinese Journal of Neurosurgery. 2013;29(10):975-979.

[8] Burton T, Le Nestour E, Neary M, Ludlma WH. Incidence and prevalence of acromegaly in a large US health plan database. Pituitary. 2016;19:262-267.

[9] Chinese Society of Endocrinology, Chinese Pituitary Adenoma Collaborative Group. Guidelines for the Diagnosis and Treatment of Acromegaly in China[J]. Chinese Journal of Practical Internal Medicine, 2013(7):519-524.

[10] Mestron A, Webb SM, Astorga R, et al. Epidemiology, clinical characteristics, outcome, morbidity and mor­tality in acromegaly based on the Spanish Acromegaly Registry (Registro Espanol de Acromegalia, REA). Eur J Endocrinol. 2004;151:439-446

[11] Pouget E et al. J Am Chem Soc. 2010; 132:4230-41.

[12] Orlewska E, Kos-Kudla B, Sowinski J, et al. Endokrynol Pol. 2015;66(2):142-8.

[13] Dekkers OM et al. J Clin Endocrinol Metab. 2008; 93:61-67

[14] Ritvonen E et al. Endocr Relat Cancer. 2016; 23(6):469-80;

[15] Dal J. Eur J Endocrinol. 2016 Sep;175(3):181-90;