According to a story from pm360online.com, the global biotechnology company Shire plc recently announced its product Takhzyro (injectable lanadelumab) was approved by Health Canada after priority review. Takhzyro is indicated as a periodic, routine treatment for swelling attacks that occur with the rare condition hereditary angioedema. The drug is approved for patients that are age 12 or older.
About Hereditary Angioedema
Hereditary angioedema is a genetic disorder which is characterized by chronic episodes of swelling that can affect multiple areas of the body. The condition is caused by mutations affecting the HAE gene. Swelling attacks generally occur every two weeks or so; they can usually last for several days. Swelling may affect the limbs, digestive tract, face, and airway, with blockage of the airway being the most dangerous complication. Vomiting and abdominal pain may accompany attack as well if the digestive tract is involved. Treatment involves reducing the likelihood for attacks to appear and preventing them from worsening when they do. Hereditary angioedema is typically only life-threatening if left untreated. Prevalence of the condition is estimated to be around one in 10,000 to one in 50,000, at least in the US and Canada. To learn more about hereditary angioedema, click here.
Takhzyro is typically dosed at two week intervals, similar to the average frequency of hereditary angioedema attacks. However, if patients seem to be responding well for a period of six months, this dose can be dialed back to about once a month. The drug has performed impressively in trials; at two week intervals, it was able to reduce the amount of swelling attacks per month by 87 percent, and at four weeks intervals, it could reduce the amount by 73 percent. Side effects are also relatively mild and are limited to reactions at the injection site. The injection can also be self-administered.
The approval of Takhzyro by Health Canada follows relatively closely behind the approval of the drug in the US, which was first cleared on August 23rd for the same indication. It should be noted that this drug is meant for prevention of attacks and is not meant to bring down a swelling episode that has already begun.