EMA Recommends mAb for Treatment of Hereditary Angioedema
Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
On October 19, 2018, the European Medicines Agency (EMA) announced it had granted marketing authorization to Takhzyro (lanadelumab). The biologic is the first monoclonal antibody therapy (mAb) for the treatment of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
HAE is a rare, long-term debilitating disease caused by abnormalities in the gene responsible for the production of C1 esterase inhibitor. Patients with HAE experience swelling beneath the skin that can occur anywhere in the body including the limbs, gut, larynx, and face. Swelling in the larynx may be life threatening. According to EMA, Takhzyro (lanadelumab) recognizes and attaches to kallikrein proteins, blocking the activity of the kallikrein-kinin system and reducing the number of angioedema attacks.
EMA’s Committee for Medicinal Products for Human Use determined that Takhzyro, which is administered subcutaneously every two to four weeks, improves patient care compared to current therapies that are administered either intravenously or more frequently. The committee, therefore, agreed to accelerated assessment and recommendation of this medicine.
Source: EMA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
