New drug approvals - August 2021

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Product Name

LEQVIO SOLUTION FOR INJECTION IN PREFILLED SYRINGE 284 MG/1.5 ML

Active Ingredient

Inclisiran sodium eqv inclisiran

Application type

NDA-1: New chemical entity

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

03/08/2021

Registration No.

SIN16295P

Indications:

Treatment in adults with primary hypercholesterolaemia (including heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,

• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

*Evaluated via Access

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals