Otsuka’s Hereditary Angioedema Drug Set to be Commercialized in Europe
Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of swelling in various parts of the body, including the hands, feet, face, and airways. These episodes can be painful and potentially life-threatening if they affect the airways. Otsuka Pharmaceutical Co., Ltd., a leading global healthcare company, has developed a breakthrough drug to treat HAE, and it is now set to be commercialized in Europe.
The drug, known as Orladeyo (berotralstat), is an oral therapy that works by inhibiting plasma kallikrein, an enzyme involved in the production of bradykinin, a key mediator of swelling in HAE. By reducing the levels of bradykinin, Orladeyo helps prevent the recurrent swelling episodes associated with HAE.
Orladeyo has shown promising results in clinical trials. In a Phase 3 trial involving 121 patients with HAE, the drug significantly reduced the rate of HAE attacks compared to a placebo. Patients treated with Orladeyo experienced a 44% reduction in the mean number of monthly attacks, compared to a 14% reduction in the placebo group. The drug also demonstrated a favorable safety profile, with the most common side effects being mild to moderate and transient.
The European Medicines Agency (EMA) has recently granted Orladeyo marketing authorization for the treatment of HAE in Europe. This approval marks a significant milestone for patients suffering from this debilitating condition, as it provides them with a new treatment option that can help prevent and manage their symptoms.
The commercialization of Orladeyo in Europe is expected to have a positive impact on the lives of HAE patients. Currently, treatment options for HAE are limited and often involve intravenous infusions or injections, which can be inconvenient and burdensome for patients. Orladeyo’s oral formulation offers a more convenient and patient-friendly approach to managing HAE, allowing patients to take the medication at home without the need for healthcare professional assistance.
Furthermore, Orladeyo’s ability to prevent HAE attacks can significantly improve the quality of life for patients. By reducing the frequency and severity of swelling episodes, patients can experience fewer disruptions to their daily activities, such as work, school, and social engagements. This can lead to improved productivity, increased independence, and a better overall well-being.
Otsuka is committed to ensuring the availability and accessibility of Orladeyo to HAE patients in Europe. The company is working closely with healthcare providers, patient organizations, and regulatory authorities to ensure a smooth and timely launch of the drug. Otsuka also plans to provide comprehensive support programs for patients, including educational resources, patient assistance programs, and access to healthcare professionals specialized in HAE management.
In conclusion, the commercialization of Otsuka’s Orladeyo in Europe represents a significant advancement in the treatment of hereditary angioedema. This breakthrough drug offers a convenient and effective oral therapy option for HAE patients, helping to prevent and manage their symptoms. With its proven efficacy and favorable safety profile, Orladeyo has the potential to greatly improve the lives of HAE patients by reducing the frequency and severity of swelling episodes. Otsuka’s commitment to supporting patients and ensuring access to this innovative treatment further underscores the company’s dedication to improving healthcare outcomes for rare disease populations.
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