If you have any question, please feel free to email us. We will touch with you as soon as possible.
Recently, the British Drug and Health Product Authority (MHRA) approves Anstel to prostate cancer drug XTANDI (Enzalutamide, Enzacus) for the treatment of metastatic hormone sensitive prostate cancer (MHSPC) adult male patients.
As this approval, Xtandi became the only one of MHRA-approved oral therapy that could treat three advanced prostate cancer, including high-risk metastasis and metastatic disorders resistance prostate cancer (NMCRPC, MCRPC), and MHSPC. Xtandi has become a standard nursing therapy for patients with advanced prostate cancer. Since the first approval of 2012, more than 610,000 patients have been treated.
Xtandi was first developed by the US Medivation, and authorized by the United States to give Anste. Pfizer acquired MediVation $ 14 billion in August 2016. At present, Xtandi is jointly promoted by Pfizer and Anste.
MHSPC is a predetermoy of prostate cancer, but there is still a therapeutic response to androgen deprived therapy (ADT), which is limited in the treatment of such patients. Many patients have a poor prognosis. The latest approval will provide an urgent, additional treatment option to MHSPC adult male patients, helping to improve prognosis. At the same time, health care professionals will also choose to provide Xtandi treatment throughout the advanced prostate cancer disease.
This approval is based on the results of the 3 issue ARCHS test. Data show that the XTANDI + ADT scheme significantly reduced MHSPC male patient imaging in MHSPC male patient imaging in the XTANDI + ADT scheme significantly reduced by 61% compared with placebo + Androgens deprived therapy (ADT). The safety analysis of this trial is consistent with the safety analysis of Xtandi in the previous CRPC test, and the incidence of 3 or higher-level adverse events in patients treated by Xtandi + ADT and placebo + ADT is similar, which is 24.3% and 25.6%, respectively. .
On the same day, the British National Health and Health Care Institute (Nice) released a final guide to refuse Pfizer VyndaQEL (Tafamidis, 61mg) to incorporate the British National Medical Services (NHS) for the treatment of rare heart diseases - Antariocephagia (ATTR-CM).
In the UK, there are about 800 people with ATTR-CM. This is a rare, insufficient diagnosis, dangerous disease, characterized by an abnormal deposition of erroneous folding proteins called amyloid proteins in the heart . Once diagnosed, the average expected life of ATTR-CM patients depends on subtypes for approximately 2-3.5 years.
NICE pointed out that VYNDAQE is cost-effective estimate above NHS resources is usually considered acceptable. The agency said that there is not enough evidence that VYNDAQE drug recommendations can reduce diagnostic delays, and once the treatment is stopped, the long-term benefits of VyndaQEL will be more uncertain.
But at the same time, Nice "is still keen to ensure that ATTR-CM patients get VyndaQEL. The agency said that if NHS and Pfizer have reached an agreement on a new value proposition, the drug has cost effectiveness, which is willing to conduct a quick review of the final guide.
VYNDAQE (Tafamidis, 61mg) received the EU approval in February 2020 to become the first drug for treating Attr-cm. This approved data based on the 3-phase ATTR-ACT study. This is the only global, double blind, random, placebo, aimed to study drug treatment of ATTR-CM. Studies have shown that VYNDAQEl reduces all-lived mortality and cardiovascular hospitalization rate compared to placebo in wild-type or genetic ATTR-CM patients.
Tel:+86-020-61855200-902
Fax:+86-020-66392525
Email:info@upharm.cn
Address:12th floor, No. 181, Kexue Avenue, Huangpu District, Guangzhou, China