[heavyweight] up to date! India's first new generic drug was approved by FDA, and GlaxoSmithKline's new asthma drug was approved by FDA

On May 23, 2018, sun Pharmaceutical Co., Ltd., including its subsidiaries and Churchill pharmaceuticals, LLC announced that FDA approved yonsa (abiraterone acetate) for the treatment of metastatic castration resistant prostate cancer The new drug is a new preparation combined with methylprednisolone, which has a significant effect on metastatic castrated prostate cancer (mcrpc) It is worth noting that this is not the first new drug approved by generics In April 2018, the company has obtained the first FDA approval for new drugs, and the biological monoclonal antibody tidrakizumab has been approved for the treatment of moderate to severe psoriasis Yonsa is a CYP17 inhibitor that uses proprietary solumatrix fine particle technology Gamma To develop a new dosage form of micronized (small particle size) abiraterone acetate tablets, and at the same time to achieve the purpose of treatment of metastatic castration resistant prostate cancer by effective combination of methylprednisolone The therapeutic mechanism is: CYP17 enzyme is expressed in testis, adrenal gland and prostate tumor tissue, which is necessary for androgen biosynthesis The active component of the drug is transformed into abiraterone (this is an androgen biosynthesis inhibitor, which can inhibit 17 hydroxylase / c17,20 lyase), which will directly control the expression of this key enzyme, and then play the drug efficacy The invention of this inhibitor can be described as the optimized product of abiolone acetate It inherits the characteristic pharmacological effect of abiolone acetate, but it may also include the liver toxicity defect of abiolone acetate According to the previous market data, patients suspected of taking acetic acid products will cause serious liver function toxicity, including fulminant hepatitis, acute liver failure and death Therefore, it is necessary for patients to follow up and monitor the changes of serum transaminase (ALT and AST) and bilirubin level regularly when taking this kind of products At the same time, clinical research shows that the most common adverse reactions may occur during the use of this product are: fatigue, joint swelling or discomfort, edema, hot flashes, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion It is worth mentioning that at present, the main drug for the treatment of metastatic castrated prostate cancer (mcrpc) is abitrone acetate tablets According to the data of drug intelligence, there is only one imported drug produced by Janssen cilag international N.V in the list of drugs on the market in China As the first batch of enterprises in China to be undertaken by generic application type, there are only three enterprises, namely, Zhengda Tianqing Pharmaceutical Group Co., Ltd., Chengdu Shengdi Pharmaceutical Co., Ltd and Jiangxi Shanxiang Pharmaceutical Co., Ltd (see the figure below for details) yonsa and methylprednisolone are the new drug application (NDA) applied under 505 (b) (2) regulatory approach, and become the company's brand booster product in the United States "We are pleased to add yonsa to our growing cancer portfolio and continue to deliver on sunpharma's promise to enhance patients' access to innovative cancer treatments," said Abhay gandh, CEO of sun pharmaceutical's North American subsidiary, on the approval of the new drug Note: the 505 (b) (2) new drug application (NDA) path of FDA, a simplified procedure most commonly used for new dosage forms and new formulations of existing drugs, does not shorten the review time New drugs for the treatment of 5-11-year-old children's asthma have been approved by the FDA GlaxoSmithKline, a GSK firm in the field of asthma, announced that arnulity has been approved by the U.S Food and Drug Administration (FDA) for the use of a daily inhaled corticosteroid (ICS) drug in 5-year-old children, which is suitable for the treatment of children's asthma This makes arnuity one of the few asthma treatments in the United States for this young age group The new drug is approved for prophylactic treatment of asthma in children aged 5-11 years as a 50 microgram daily elipta inhaler There was no significant therapeutic effect on acute bronchospasm Arnulity ellipta (100mcg and 200mcg), an inhaled corticosteroid (ICS), was approved in the United States in August 2014 for the treatment of asthma in patients over 12 years old Arnubity's successful approval benefited from a report that included data from a key study The study evaluated the efficacy and safety of daily fluticasone and placebo use in 593 asthmatic children aged 5 to 11 years The primary end point of the 12 week study was the average change in peak expiratory flow (PEF) in the morning, a measure of lung function The results showed that the incidence of adverse events (ITT population) in this age group was 29% in placebo group and 32% in furoate 50mcg group Source: https://www.drugs.com/news.html