Inclisiran
Inclisiran (development codes ALN-PCSsc, ALN-60212) is an experimental drug for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents and heterozygous familial hypercholesterolemia (HeFH). 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]
On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Leqvio, intended for the treatment for primary hypercholesterolaemia or mixed dyslipidaemia.[7]
See also
- Hypercholesterolemia (elevated cholesterol)
References
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. 382. Jahrgang, Nr. 16, März 2020, S. 1507–1519, doi:10.1056/NEJMoa1912387, PMID 32187462.
External links
- Inclisiran. In: Drug Information Portal. U.S. National Library of Medicine
- Vorlage:ClinicalTrialsGov
- Vorlage:ClinicalTrialsGov
Vorlage:Cardiovascular-drug-stub
- ↑ 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).
- ↑ Spreitzer H: Neue Wirkstoffe: Inclisiran. In: Österreichische Apotheker-Zeitung. Nr. 19/2017, 11. September 2017.
- ↑ Proposed INN: List 114. In: WHO Drug Information. 29. Jahrgang, Nr. 4. WHO, 2015, S. 531 f. (who.int [PDF]).
- ↑ Nick Paul Taylor: Medicines Company's PCSK9 drug hits phase 3 efficacy goals. In: FierceBiotech. 26. August 2019 .
- ↑ The Medicines Company Announces Positive Topline Results from First Pivotal Phase 3 Trial of Inclisiran. In: The Medicines Company. Abgerufen am 29. August 2019.
- ↑ Novartis acquires medicines company. In: Novartis. Abgerufen am 15. Januar 2020.
- ↑ Leqvio: Pending EC decision. In: European Medicines Agency (EMA). 16. Oktober 2020, abgerufen am 16. Oktober 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.