These 8 drugs face FDA regulatory review decision in January 2020

Compile newborn Last Friday, AstraZeneca and HER2, the first three co products, got the approval of the US FDA in advance, much earlier than the target date of PDUFA in April 2020 According to evaluatepharma, in addition to enhertu, the FDA has approved several drugs in advance in the fourth quarter, including: trikafta, vertex cystic fibrosis triple therapy, padcev, brukinsa, brukensa, Baji Btk inhibitor, oxbryta, adakveo and Alnylam acute liver porphyrin Disease drug givlaari In January 2020, there will be a number of drugs facing important FDA review decisions The following are the more important ones: The drug is an oral, powerful and pioneering EZH2 inhibitor developed by epizyme EZH2 is a kind of histone methyltransferase If it is activated abnormally, it will lead to the disorder of gene controlling cell proliferation, which can cause unlimited and rapid growth of non Hodgkin's lymphoma and many other solid tumor cells Tazemetostat has antitumor effect by inhibiting EZH2 enzyme activity In clinical research, tazemetostat showed the ability to reduce or even eliminate tumor safely and effectively in the early stage of treatment Currently, the drug is under FDA review for the treatment of metastatic or locally advanced epithelioid sarcoma (ES) patients who are not suitable for curative surgery Last week, the FDA's Advisory Committee on oncology supported the benefit risk ratio of the drug by a full vote (11:0) Phase II data showed that: in the initial treatment patients, the objective response rate (ORR) was 25%, the median response duration (DOR) was 41.1 months, the disease control rate (DCR) was 42%, and the median total survival period (OS) was not reached; in the relapsed or refractory patients, the orr was 8%, the Dor was not reached, the DCR was 16%, and the median OS was 47.4 months; in the whole study population, the orr was 15%, the Dor was not reached, and the DCR was 26% The median OS was 82.4 months Despite the low response rate, the FDA panel believes that the proportion and duration of response are clinically significant Some analysts pointed out that there is a serious lack of approved treatment options in the field of ES, which will facilitate the approval of tazemetostat At present, epizyme is also developing the drug to treat recurrent or refractory follicular lymphoma The drug is an antibiotic product developed by mosadon and Astaire It is a large ring lipid antibiotic with a new mechanism of action and a selective antibacterial spectrum The drug mainly produces rapid anti refractory Clostridium infection by inhibiting RNA polymerase of bacteria At present, the application of dificid oral suspension and tablet for new drug supplementation is under FDA review for the treatment of Clostridium difficile infection in children aged 6 months and over Previously, the drug has been awarded orphan drug qualification for pediatric indications In the United States, dificid has been approved for the treatment of C difficile associated diarrhea in adults In order to reduce the formation of resistant bacteria and maintain the effectiveness of dificid and other antimicrobial agents, dificid should only be used for the treatment of infection caused by Clostridium difficile that has been confirmed or strongly suspected The drug is an oral biological immunotherapy developed by aimmune therapeutics based on the proprietary oral desensitization immunotherapy treatment platform It is used for children and adolescents aged 4-17 who are allergic to peanuts to reduce the incidence and severity of anaphylaxis after accidental intake of peanuts In September, palforzia obtained the review opinion recommended and approved by the FDA allergic Products Advisory Committee Peanut allergy is one of the most common food allergies At present, there is no approved treatment The standard care has always been to strictly exclude diet and timely give rescue drugs in case of allergic reactions caused by accidental intake If approved, palforzia will be the first treatment for peanut allergies, with evaluatepharma predicting sales of $1.279 billion in 2024 The drug (rimegepant orally disintegrating tablet) is a migraine drug developed by biohaven, and its application for acute treatment of migraine is under FDA review In the critical phase III clinical treatment of acute migraine, compared with placebo, patients treated with single dose rimegepant orally disintegrating tablet experienced rapid and lasting clinical benefits, and the pain and migraine related symptoms were relieved rapidly and effectively 2 hours after taking the drug At present, rimegepant has also entered phase III clinical practice to prevent migraine attack In October this year, leyvow was approved by FDA as a 5-HT1F agonist, becoming the first new type of acute migraine treatment drug approved in 20 years On Monday, embrevy was approved by the FDA for acute treatment of adult migraine (with or without aura), becoming the first oral CGRP receptor antagonist approved for migraine attack in the world However, going public first doesn't necessarily bring you the last laugh The data of phase III study of acute migraine show that rimegepant is better than ubralvy and reyvow is better than rimegepant, but reyvow has side effects and is controlled by DEA Evaluatepharma forecasts that rimegepant's sales will reach $897 million in 2024, while reyvow's and ubralvy's sales will reach $317 million and $302 million in the same period At present, the supplementary application for the treatment of non responsive, high-risk non muscle invasive bladder cancer (NMIBC) with BCG is under FDA review Last week, the FDA's Advisory Committee on cancer drugs voted 9:4 for approval If approved, keytruda will be the first PD - (L) 1 treatment for NMIBC Data from keynote-057 in phase II study showed that the complete remission rate was 41% and the median remission duration was 16.2 months after keytruda treatment for 3 months One year later, 46% of the initial responders maintained remission, accounting for 19% of all patients in the efficacy analysis, which was lower than the 30% standard recommended by the international bladder cancer group Currently, MSD is carrying out the verification test of keynote-676 The two drugs were developed by Novo Nordisk, and the active ingredients were semaglutide Ozempic is a weekly subcutaneous injection preparation, rybelsus is a daily oral preparation, the indications are: combined with diet and exercise, improve the blood glucose control of adult patients with type 2 diabetes Rybelsus, approved in September this year, is the first and only oral GLP-1 receptor agonist in the world At present, the two drugs to reduce cardiovascular (CV) risk of supplementary applications are under FDA review The application is based on the results of two cardiovascular prognosis studies (Pioneer 6, sustain 6), which were conducted in adults with type 2 diabetes at high risk of CV events The data showed that rybelsus and ozempic reduced the risk of composite endpoints of major adverse cardiovascular events by 21% and 26%, respectively, when compared with placebo, when combined with standard care However, the pioneer 6 study only showed non inferiority rather than superiority, while the sustain 6 study did not include the superiority analysis specified in advance It is not clear that these two drugs can win CV indications, and Novo Nordisk may need to wait for data from larger cardiovascular studies, such as the soul study on rybelsus, launched earlier this year, involving 9600 patients The drug is developed by AstraZeneca, and the supplementary application for the first-line chemotherapy of extensive small cell lung cancer (es-sclc) is under the priority review of FDA In March this year, Roche tecentriq took the lead in obtaining FDA approval Combined with chemotherapy, the first-line treatment of es-sclc is the first and only cancer immune program approved for early treatment of es-sclc, and the first new first-line treatment program approved for es-sclc in the past 20 years Imfinzi may enter the field of first-line small cell lung cancer with this approval In the phase III CASPIAN study, the total survival time of the imfinzi + chemotherapy group was significantly longer than that of the chemotherapy group (median OS: 13.0 vs 10.3 months) This data is comparable to the results of tecentriq phase III study: compared with the chemotherapy group, tecentriq + chemotherapy group significantly prolonged OS (median OS: 12.3 vs 10.3 months).