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Pasireotide
Pharmaceutical drug

Pasireotide, sold under the brand name Signifor, is an orphan drug approved in the United States and the European Union for the treatment of Cushing's disease in patients who fail or are ineligible for surgical therapy. It was developed by Novartis. Pasireotide is a somatostatin analog with a 40-fold increased affinity to somatostatin receptor 5 compared to other somatostatin analogs.

The most common side effects include hyperglycaemia (high blood sugar levels), diabetes, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick), cholelithiasis (gallstones), injection site reactions, and tiredness.

Pasireotide was approved for Cushing's disease by the European Medicines Agency (EMA) in April 2012 and by the U.S. Food and Drug Administration (FDA) in December 2012.

Pasireotide LAR (the long-acting-release formulation) was approved by the FDA for treatment of acromegaly in December 2014, and had been approved for this indication by the EMA in September 2014.

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References

  1. "Drug Approval Package: Signifor (pasireotide) Injection NDA #200677". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 13 May 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000TOC.cfm ↩

  2. "Signifor EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 May 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. https://www.ema.europa.eu/en/medicines/human/EPAR/signifor ↩

  3. "Summary of Product Characteristics: Signifor" (PDF). European Medicines Agency. Archived from the original (PDF) on 14 June 2018. Retrieved 27 September 2016. https://web.archive.org/web/20180614200149/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002052/WC500128056.pdf ↩

  4. "Pasireotide Orphan Drug Designation and Approval". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 13 May 2020. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=288709 ↩

  5. "EU/3/09/671". European Medicines Agency. 17 September 2018. Retrieved 13 May 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu309671 ↩

  6. Mancini T, Porcelli T, Giustina A (October 2010). "Treatment of Cushing disease: overview and recent findings". Therapeutics and Clinical Risk Management. 6: 505–16. doi:10.2147/TCRM.S12952. PMC 2963160. PMID 21063461. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2963160 ↩

  7. "Signifor EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 May 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. https://www.ema.europa.eu/en/medicines/human/EPAR/signifor ↩

  8. "Signifor- pasireotide injection". DailyMed. 15 January 2020. Retrieved 13 May 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=442f0d9d-5c7d-4b81-b329-d71be8cf2be2 ↩

  9. "Signifor LAR- pasireotide kit". DailyMed. 17 December 2019. Retrieved 13 May 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5504116c-d531-4d47-b160-41c6671d52aa ↩

  10. "Signifor EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 May 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. https://www.ema.europa.eu/en/medicines/human/EPAR/signifor ↩

  11. "EMEA Approval for Pasireotide". Archived from the original on 4 February 2014. Retrieved 26 January 2014. https://web.archive.org/web/20140204042347/http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Fhuman%2Forphans%2F2009%2F11%2Fhuman_orphan_000677.jsp ↩

  12. "Drug Approval Package: Signifor (pasireotide) Injection NDA #200677". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 13 May 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000TOC.cfm ↩

  13. "FDA Approves Pasireotide for Cushing's Disease". http://www.medscape.com/viewarticle/776273 ↩

  14. "Signifor LAR (pasireotide) for injectable suspension". U.S. Food and Drug Administration (FDA). 1 March 2016. Retrieved 13 May 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000TOC.cfm ↩

  15. "Signifor EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 May 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. https://www.ema.europa.eu/en/medicines/human/EPAR/signifor ↩

  16. Tucker ME (17 December 2014). "FDA Approves Pasireotide for Treating Acromegaly". Medscape. Retrieved 2 August 2015. http://www.medscape.com/viewarticle/836728 ↩