List of new drugs approved by CDER in 2019! Novartis, Aberdeen, Genentech

In 2019, the FDA Center for drug review and Research (CDER) approved 48 new drugs, including 37 new molecular entities (NME) and 11 biological product licensing applications (BLA)Compared with 59 in 2018, the total number decreased by 11, down 18.64% year on year< br / > Figure 1: Statistics of new drugs approved by CDER in recent 10 years < br / > for rare diseases / orphan drugs, 20 new drugs have obtained orphan drug qualification (o), accounting for 41.67% of new drugs approved by CDERThere are two characteristics of rare diseases, one is the small number of patients, and the United States is less than 200000 peopleThe second is serious diseases endangering life and health< br / > in terms of priority review, drugs will be given priority review if CDER determines that drugs have the potential to substantially promote health careThe drug is reviewed within 6 months instead of the standard 10 monthsAmong the approved new drugs in 2019, 25 were identified as priority review (P), accounting for 52.08% of the 48 new drugs< br / > CDER uses a variety of regulatory methods to accelerate the development and approval of new drugsIn addition to the priority review, these methods include fast track, breakthrough and accelerated approvalIn 2019, five drugs were approved for breakthrough treatment: zulresso, balversa, poly, turalio, rozlytrek< br / > in terms of enterprises, Novartis received the largest number of approvals, reaching five new drugsSecondly, first trimethoprim, Abercrombie and Genentech obtained two new drugs respectivelyBaiji Shenzhou has also obtained a new drug, zebutini, which is the first Chinese self-developed new anti-cancer drug approved for market in the United States< br / > Figure 2: in terms of the number of new drugs approved by enterprises in 2019 < br / > in terms of the time of approval, only no new drugs approved in JanuaryNew drugs were approved mainly in the second half of the year, with the largest number in August, and 9 new drugs were approved< br / > Figure 3: the number of new drugs approved in each month in 2019 < br / > the figure below is a summary of 48 new drugs approved in 2019, which comes from the FDA website, new drug approvals for 2019 < br / > Table 1: summary of new drugs approved by FDA in 2019 < br / > variety Review < br / > 1 Jeuveau (prabotulinumtoxina xvfs) < br / > on February 1, the FDA approved jeuveau (prabotulinumtoxina xvfs) of evolus company for temporary improvement of the appearance of moderate to severe frown lines related to the activity of frown muscles and / or between brow reducers in adults < br / > the approval of jeuveau by FDA is based on the data of two phase III randomized, multicenter, double-blind, placebo-controlled studies in the United States, all of which have reached the main end point, and confirmed the effectiveness of jeuveau in improving the severity of brow wrinkles compared with placebo: on the 30th day of treatment, In jeuveau group, 67.5% (ev-001 study) and 70.4% (ev-002 study) patients achieved two consistent improvements, compared with 1.2% and 1.3% in placebo group No serious drug-related adverse events were reported in either study On February 6, the FDA approved the development of caplacizumab yhdp by Sanofi for the treatment of adult acquired thrombocytopenic purpura (attP) Cablivi is the first specific attP treatment drug and the first approved nano antibody drug The efficacy of < br / > cablivi was based on a clinical trial involving 145 patients who were randomized to cablivi or placebo Two groups of patients received plasma exchange and immunosuppressive therapy The results showed that patients treated with cablivi had a faster improvement in platelet count and a reduction in the total number of attP related deaths and relapses during treatment compared to placebo Throughout the study period (drug treatment plus 28 day follow-up after discontinuation), the recurrence rate was 38% in the placebo group and only 13% in the cablivi group On February 13, the US FDA approved the launch of Novartis' egaten (triclabendazole) for the treatment of patients over 6 years old with Fasciola This is the only FDA approved treatment for the disease < br / > paragonimiasis, also known as liver fluke infection, is a neglected tropical disease There are about 2.4 million patients around the world, and another 180 million people are at risk It is caused by two parasitic flatworms that can enter the body when people eat food contaminated by larvae If not treated, Fasciola can cause severe pain and discomfort, leading to a decline in quality of life and productivity On March 19, the FDA approved zulreso (brexanolone) injection of sage therapeutics for the treatment of postpartum depression (PPD), which is the most common delivery complication This approval makes zulreso the first and only drug approved to treat PPD in the world The approval of < br / > zulreso was based on data from three multicenter, randomized, double-blind, parallel group, placebo-controlled clinical studies These studies evaluated the efficacy and safety of zulreso injection in the treatment of moderate to severe PPD The study enrolled 18-45-year-old pregnant women who developed severe depressive symptoms no earlier than the third trimester and no later than the fourth week after delivery, and the time of the study was earlier than six months after delivery On March 20, the FDA approved sonosi (solriamfetol) from jazz pharmaceutical company to treat adult patients with daytime hypersomnia (EDS) related to narcolepsy or obstructive sleep apnea (OSA) < br / > the approval of sunosi by FDA is based on the data of phase III clinical project tones This project includes four randomized and placebo-controlled studies, namely: the treatment of EDs in adult patients with narcolepsy (the tones-2 study), the treatment of EDs in adult patients with OSA (the tone-3 study, the tone-4 study), and the long-term safety and maintenance effect study (the tones-5 study) for adult patients with narcolepsy or OSA in the treatment of EDs Data from these studies confirm sunosi's superiority over placebo in the treatment of EDS related to narcolepsy and OSA On March 26, the U.S FDA approved the launch of mayzent (siponimod) from Novartis for the treatment of adult patients with relapsing multiple sclerosis (RMS), including active secondary progressive disease (active SPMS), relapsing remission disease (RRMS) and clinical isolated syndrome (CIS) < br / > this approval is based on mayzent's performance in a randomized, double-blind, placebo-controlled phase 3 clinical trial called expand Compared with placebo, mayzent significantly reduced the risk of confirmed disability progression (CDP) after 3 months, and 21% lower than placebo (P = 0.013) In addition, mayzent significantly delayed the risk of CDP by 6 months, which was 26% lower than that of placebo (P = 0.0058) At the same time, mayzent reduced the annual recurrence rate by 55% On April 9, the FDA approved aejin's aeynity (romosozumab) as an indication of osteoporosis in postmenopausal women with high risk of fracture Aeynity has become the world's first anti sclerostin monoclonal antibody drug approved for marketing, which can not only accelerate bone formation but also reduce bone absorption < br / > evenity is jointly developed by Amgen and youshibi on a global scale In January, evenity was approved in Japan for use in men at high risk of fracture and postmenopausal women with osteoporosis, reducing the risk of fracture and increasing bone density This approval is also the first regulatory approval for evenity worldwide In early March of this year, evenity was on sale in the Japanese market At present, evenity is also under review by the European Drug Administration (EMA) Balversa (erdafitinib) < br / > on April 12, FDA approved balversa (erdafitinib) of Janssen to be on the market for the treatment of locally advanced or metastatic bladder cancer with FGFR3 or FGFR2 mutations in the progression of disease after chemotherapy with platinum therapy < br / > balversa is an oral pan FGFR inhibitor FGFRs is a family of receptor tyrosine kinases, which can be activated by gene mutations in different tumors, thus promoting the survival and proliferation of tumor cells In addition, balversa is the first FDA approved targeted therapy for metastatic bladder cancer 9.Skyrizi (risankizumab-rzaa) 4 on 23, the FDA approved the listing of Skyrizi (risankizumab-rzaa) for systemic or phototherapy in patients with severe psoriasis and plaque psoriasis < br / > skyrizi is an interleukin-23 (IL-23) inhibitor, which is believed to be associated with several chronic immune-mediated diseases, including psoriasis and inflammation Skyrizi can selectively block IL-23 by binding with P19 subunit, so as to treat related skin diseases Vyndaqel (tafamidis meglumine) < br / > on May 3, the FDA of Pfizer approved vyndaqel (tafamidis meglumine) for the treatment of adult patients with wild-type or hereditary ttr-cm to reduce the incidence of cardiovascular death and cardiovascular related hospitalization < br / > this FDA approval is based on data from the critical clinical phase 3 trial attr-act, the first global double-blind, randomized, placebo-controlled clinical study for the treatment of the disease The data showed that compared with placebo, vyndaqel significantly reduced all-cause mortality and cardiovascular related hospitalization rate (P = 0.0006) by 30% (P = 0.026) and 32% (P < 0.0001), respectively In both treatment groups, about 80% of deaths were cardiovascular related On May 24, the U.S FDA approved the launch of Novartis' piqray (alpelisib), which was used in combination with the endocrine drug fulvestrant, to treat postmenopausal women and men with specific advanced or metastatic breast cancer These patients were hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER-2) negative and carrying PIK3CA mutation, and progressed during or after endocrine therapy This is also the first pik3 inhibitor approved by FDA < br / > at the same time, FDA has also approved the matching diagnostic test therascreen PIK3CA rgq PCR kit for the mutation of PIK3CA in tissue or liquid biopsy Patients with negative therascreen test using liquid biopsy should receive tumor biopsy to determine the mutation of PIK3CA On June 10, the U.S FDA approved the use of polatuzumabvedotin piiq in combination with rituximab and chemotherapy for patients with diffuse large B-cell lymphoma who had failed or relapsed at least two times The positive test results of < br / > poly in phase 1B / 2 finally led to the green light of supervision The results showed that the efficacy of the combination was better than that of bentamoxetine and rituxan In this trial, 40% of the patients used the combination of poly to achieve complete response, while the response rate of bendamoxetine and rituxan group was only 18% At the end of the treatment, 45% of the patients in the Poly Group achieved objective response, while only 18% of the patients in the bendamoxetine and rituxan groups achieved objective response On June 21, the U.S FDA approved the listing of vyleesi (bremelaniotide) for the treatment of acquired and generalized hyposexuality (HSDD) in premenopausal women Vyleesi, which was jointly developed by AMAG Pharmaceuticals and PalatinTechnologies, is the first melanocortin 4 receptor agonist The approval of < br / > vyleesi was based on two large, randomized, double-blind, placebo-controlled, three-phase clinical trials involving 1247 premenopausal women with HSDD Both trials achieved a common primary end point, and the score of libido index of the treated women was significantly better than that of the control group