Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said it has received marketing approval from the authorities in Brazil for specialist cholesterol drug Lojuxta.
The rare diseases specialist noted that the drug is used to treat homozygous familial hypercholesterolaemia (HoFH), a rare condition where the body finds it difficult to remove bad cholesterol from the blood.
It has been approved by the regulator ANVISA for use alongside a low-fat diet and other lip-lowering drugs.
In a statement, Amryt's chief executive, Dr Joe Wiley, said: “We are pleased that ANVISA has recognised the significant unmet medical need of patients in Brazil suffering from HoFH and have approved marketing authorisation for Lojuxta to treat adults with this condition.
“Today’s news is another milestone in executing our strategy to make Lojuxta available to HoFH patients in need globally.”
Lojuxta is one of two commercial drugs Amryt has on the market. The other is Myalept, which is approved in the US to treat the complications of leptin deficiency.
The group is preparing to seek regulatory sign-off for FILSUVEZ, developed for epidermolysis bullosa (EB), a chronic and distressing genetic skin disorder that causes the skin layers and internal body linings to separate.
