LONDON (Alliance News) - Shire PLC said Friday its Takhzyro injection has been approved in Europe to treat hereditary angioedema.
Takhzyro is a preventative treatment for hereditary angioedema, a disease that causes attacks of swelling over the body. If swelling blocks a patient's airways this can prove fatal.
The European Commission approved the drug and maintained its orphan drug designation for Takhzyro, a designation reserved for drugs to treat or prevent rare and serious conditions.
Pharma companies benefit from orphan drug designation as it can result in a possible 10-year period of market exclusivity, fee waivers, and assistance in marketing authorisation.
Shire published the results of its phase three Help study of Takhzyro on Wednesday. This study showed the drug reduced the mean number of hereditary angioedema attacks by 87% versus placebo when given as a 300 milligram injection every two weeks.
The active ingredient in Takhzyro is lanadelumab, which inhibits the enzyme plasma kallikrein. This enzyme is uncontrolled in patients with hereditary angioedema and blocking this enzyme helps prevent attacks.
Lanadelumab is a fully human monoclonal antibody, monoclonal meaning that they are made by identical immune cells that are clones of a single cell.
Antibodies are usually produced by the immune system in response to viruses and bacteria and bind to those pathogens, blocking their ability to function.
In the case of lanadelumab, the ovary cells of hamsters were genetically modified to produce these antibodies. As the DNA of these cells had been genetically modified, the antibodies were identical to those produced by humans.
Dublin-based Shire is being bought by Japanese firm Takeda Pharmaceutical Co Ltd for GBP46 billion, and Takeda expects to complete the acquisition on January 8.
The last day of dealings for Shire shares will be Friday, January 4. Shire will be removed from the FTSE 100 index on Monday, January 7, according to index provider FTSE Russell.
Shares in Shire were up 0.5% at 4,527.00 pence on Friday morning in London.
