Novartis Drug Signifor Approved in EU, Marking an Advance for Patients with Inadequately Controlled Acromegaly
![](/46/pdcnewsitem/03/39/20/f4AaZJLtkHqaNZq.jpg)
The European Commission has approved Novartis's Signifor (pasireotide) as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA). Next-generation SSA Signifor offers the first alternative treatment option directly targeting the pituitary tumor for patients whose acromegaly remains inadequately controlled on currently available SSAs.
Acromegaly affects an estimated one to two in every 10,000 people in the EU. In the majority of acromegaly cases, a non-cancerous tumour in the pituitary gland leads to excess production of growth hormone (GH) and, ultimately, insulin-like growth factor-1 (IGF-1) in the body. Prolonged exposure to excess GH and IGF-1 may cause patients to experience significant physical changes including the enlargement of hands, feet, facial features, and internal organs. Moreover, acromegaly patients who do not achieve biochemical control of their disease, as measured by GH and IGF-1 levels, may face serious health consequences such as heart disease, hypertension, diabetes, arthritis, colon cancer leading to an increased risk of death. According to recent research, 45% of acromegaly patients fail to achieve the recommended levels of GH or normalized IGF-1 on current therapies.
"Acromegaly that is not properly controlled can have a devastating impact on the long-term health of patients living with this serious pituitary disorder," said Bruno Strigini, President, Novartis Oncology. "This first approval of Signifor in acromegaly marks a much needed advance in the treatment of this rare disease and we are working hard to bring this therapy to this underserved patient population worldwide in the near future."
The approval is based on data from two multicenter Phase III studies, C2402 and C2305, which respectively evaluated patients with inadequately controlled acromegaly on first-generation SSAs, and medically naïve patients who were post-surgery, or newly diagnosed patients for whom surgery is contraindicated. Both studies showed Signifor to have superior efficacy in providing biochemical control, as measured by both GH and IGF-1 levels, compared to a first-generation SSA.
The EU approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in September 2014 for Signifor for the treatment of acromegaly and applies to all 27 EU member states, plus Iceland and Norway. Additional regulatory applications for the new long acting release formulation of Signifor have been filed worldwide for the treatment of acromegaly, including an application currently filed in the US. In the EU, Signifor has orphan drug designation for acromegaly.
Related News
-
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance