Inclisiran

Vorlage:Infobox drug

Inclisiran (development codes ALN-PCSsc, ALN-60212) is an experimental drug for the treatment of elevated cholesterol, more specifically familial hypercholesterolaemia. It is a small interfering RNA that inhibits translation of the protein PCSK9.[1][2][3] It is being developed by The Medicines Company which licensed the rights to inclisiran from Alnylam Pharmaceuticals.[4]

In 2019 The Medicines Company announced positive results from pivotal phase III study (all primary and secondary endpoints were met with efficacy consistent with Phase I and II studies). The company anticipates regulatory submissions in the U.S. in the fourth quarter of 2019, and in Europe in the first quarter of 2020.[5] The Medicines Company is being acquired by Novartis.[6]

References

Vorlage:Reflist

Further reading

  • Ray KK, Landmesser U, Leiter LA, Kallend D, Dufour R, Karakas M, Hall T, Troquay RP, Turner T, Visseren FL, Wijngaard P, Wright RS, Kastelein JJ: Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol. In: N. Engl. J. Med. 376. Jahrgang, Nr. 15, April 2017, S. 1430–1440, doi:10.1056/NEJMoa1615758, PMID 28306389 (uu.nl [PDF]).
  • Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PL, Kastelein JJ: Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. In: N. Engl. J. Med. März 2020, doi:10.1056/NEJMoa1912387, PMID 32187462.


Vorlage:Cardiovascular-drug-stub

  1. Fitzgerald K, White S, Borodovsky A, Bettencourt BR, Strahs A, Clausen V, Wijngaard P, Horton JD, Taubel J, Brooks A, Fernando C, Kauffman RS, Kallend D, Vaishnaw A, Simon A: A Highly Durable RNAi Therapeutic Inhibitor of PCSK9. In: The New England Journal of Medicine. 376. Jahrgang, Nr. 1, Januar 2017, S. 41–51, doi:10.1056/NEJMoa1609243, PMID 27959715, PMC 5778873 (freier Volltext).
  2. Spreitzer H: Neue Wirkstoffe: Inclisiran. In: Österreichische Apotheker-Zeitung. Nr. 19/2017, 11. September 2017.
  3. Proposed INN: List 114. In: WHO Drug Information. 29. Jahrgang, Nr. 4. WHO, 2015, S. 531 f. (who.int [PDF]).
  4. Nick Paul Taylor: Medicines Company's PCSK9 drug hits phase 3 efficacy goals. In: FierceBiotech. 26. August 2019;.
  5. The Medicines Company Announces Positive Topline Results from First Pivotal Phase 3 Trial of Inclisiran. In: The Medicines Company. Abgerufen am 29. August 2019.
  6. Novartis acquires medicines company. In: Novartis. Abgerufen am 15. Januar 2020.