Lojuxta - opinion on variation to marketing authorisation (European Medicines Agency) - Mar 27, 2026 - "On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Lojuxta...The CHMP adopted a change to the existing indication as follows: Lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low density lipoprotein (LDL) apheresis for the treatment of adult and paediatric patients aged 5 years and older with homozygous familial hypercholesterolaemia (HoFH)....Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded."
CHMP • Homozygous Familial Hypercholesterolemia
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