Eight "blockbusters" are on the market this year!

According to the report of "2017's most noteworthy drugs" released by corewellian, 8 of the drugs on the market in 2017 will reach the blockbuster level of sales in 2021 Six of the drugs have submitted applications to FDA in the form of accelerated approval, including breakthrough therapy designation, priority review or fast track status Of the eight drugs, four are biological drugs, four are for cancer, and two are first in class The most interesting drugs in 2017 are ranked from high to low according to the sales forecast in 2021 The potential blockbuster drugs expected to be launched in 2017 are: Roche's ocrevis (ocrelizumab), for multiple sclerosis (MS); regeneron and Sanofi's dupixent (dupilumab), for allergic diseases; durvalumab of AstraZeneca, for cancer; semaglutide of Novo Nordisk, for type 2 diabetes; olumiant (barictinib) of Lilly and Incyte, for rheumatoid arthritis; ribociclib of Novartis, for cancer; avelumab, PD-L1 drug of Merck and Pfizer, for cancer; niraparib of tesaro, for cancer While kit Pharma's kte-c19 for blood cancer may not be a blockbuster, it has attracted a lot of interest from industry observers The most noteworthy drugs on the market in 2017 (analysis based on the data of March 21, 2017, in millions of US dollars) 1 Ocrevus indication: ms with multiple sclerosis Among the potential blockbuster drugs to be launched in 2017, Roche's ocrevus is expected to have the highest sales in 2021, and the drug is expected to be launched in the second quarter of 2017 (FDA approved the drug on March 29), which has an impact on the multiple sclerosis market The MS market is a very interesting market In 2010, the market of oral fengomod changed the pattern of this market However, the decline in market share of older injectable drugs, such as interferon, has been relatively slow The first generation of generic drugs (such as menta's glatiramer, glatopa) has not greatly changed the market, but the first generation of oral generic drugs may have a greater impact on the market Although this is a mature market, there is still a significant demand for new mechanisms and improved efficacy, tolerance and convenience of MS Ocrevus is the first new anti-CD20 antibody According to data published in 2015, the drug reached the end point in two key trials (Opera 1 & 2) for relapsing remitting multiple sclerosis Compared with Rebif (recombinant interferon β - 1A), the annual recurrence rate of ocrevus decreased by 47% in the 96th week The study also reached secondary endpoints, including slowing the progression of disability caused by disease progression and reducing new brain damage The safety and tolerance data of the drug are also very good What's more, the drug is the first drug proven to be effective for primary progressive sclerosis The results of the Ontario trial show that the drug can reduce the risk of clinical disability progression by more than 24% The growth of market share in the early stage may come from the second-line treatment of patients with oral drugs and the patients at risk of progressive multifocal leukoencephalopathy after the use of Tysabri (natalizumab) However, it is expected that the newly diagnosed patients will not be used until the middle stage of the market, with the establishment of prescription habits 2 Dupixent indications: dupixent, an IL-4 α subunit inhibitor of dermatitis regeneron, has been successfully used in several phase III studies of the first development of AD PDUFA, dated March 29, will be available later in 2017 (FDA approved the drug on March 28) Solo-1 and Solo-2 studies evaluated patients with mild to moderate atopic dermatitis who were unable to control their condition effectively with topical drugs At week 16, 37% and 36% of patients had skin lesions cleared or nearly cleared, respectively The curative effect of combination of drugs and corticosteroids was better than that of corticosteroids alone (39% and 12%) Although doctors are not familiar with the mechanism of action of dupixent, the powerful short-term efficacy data of the drug, coupled with the lack of existing treatment options, make dupixent expected to be widely used after marketing The phase II trial of drugs for pediatric patients is also being completed The unmet needs of such patient groups are of particular concern The approval of pediatric indications will promote drug sales In terms of asthma indications, although there is fierce competition in the severe asthma market, dupixent's approval of this indication does not significantly increase sales, but the phase III study of drugs used in eosinophil asthma has been successful 3 Indications of durvalumab: the first BLA application of durvalumab, the PD-L1 antibody of AstraZeneca for bladder cancer, was accepted by FDA in December 2016 The application has been given priority review and is expected to go public in 2017 Although the drug can provide a meaningful treatment option in the treatment of bladder cancer, the largest sales volume is expected to come from lung cancer AstraZeneca's initial goal is to obtain positive data on the use of drugs in the third-line treatment of non-small cell lung cancer (NSCLC) in the atlantinic study, and to obtain lung cancer indications in 2016 based on this However, the research results show that the data of single drug treatment is not enough to ensure that the drug continues to develop the indication of NSCLC three-line treatment, so the plan is delayed However, positive data on first-line treatment at an early stage prompted AstraZeneca to launch the mytic III study for first-line treatment of NSCLC, comparing durvalumab and tremelimumab with standard treatment It is expected that the results of mystic will be released in 2017, and the application for the indication will be submitted by the end of this year In 2016, opdivo (nivolumab), a major competitor in the field, failed in the study of NSCLC first-line treatment However, mosadong chose a relatively safe approach and only sought the approval of keytruda (pembrolizumab) for the first-line treatment of NSCLC with high expression of PD-L1, which gave durvalumab an opportunity to surpass its competitors, although it was later listed Therefore, the mystic test is critical Although many people think that the test is more risky than the typical phase III test, the success of the study may make durvalumab become the main growth engine of AstraZeneca in the next few years 4 Semaglutide indication: semaglutide, a weekly GLP1 analogue of Novo Nordisk for diabetes, submitted an application to the FDA in December 2016 based on positive data from the sustain study for type 2 diabetes The company expects the drug to be available by the end of 2017 Data from the sustain study showed that semaglutide was able to control HbA1 levels at all stages of the disease The drug can also significantly reduce the weight of patients, compared with the zenobin-2 (sustain-2), the bydureon (exenatide controlled-release dosage form) (sustain-3), and the insulin glargine (sustain-4), which have statistically significant advantages The sustain-6 study showed that the drug also improved cardiovascular function, reduced the risk of stroke by 39%, and reduced the risk of myocardial infarction by 26% If approved, semaglutide will become the fourth weekly GLP-1 analogue to be marketed after truccity (dulaglutide), anzeum (albiglutide) and bydureon In addition, Novo Nordisk is developing a daily oral dosage form of the drug If the dosage form is put on the market, it is expected to change the current treatment status of type 2 diabetes After obtaining the positive data of phase II, Novo Nordisk started the phase III pioneer study of oral semaglutide in 2016, and the first data is expected to be released in 2018 If the research is successful, it means that patients can switch from oral small molecule drug to use the drug earlier, which will have a significant impact on the market 5 Indications of lumiant: lumiant, the next generation JAK inhibitor of Lilly and Incyte, has submitted an application for rheumatoid arthritis to FDA in January 2016 Due to FDA's request for new data analysis and PDUFA date extension, the drug failed to go on sale as expected in 2016 Data from the critical phase III trial showed that although olumiant may still be warned of the risk of infection with a black box, it is the best of its kind in terms of efficacy In clinical trials, olumiant obtained positive data in patients with methotrexate for the first time (ra-begin study), patients with DMARD failure (ra-beam, ra-build) and patients with poor efficacy of anti TNF drugs (ra-beacon) Moreover, in many indicators, olumiant has been proved to be superior to Sumerian (adamumumab) It is expected that the drug will compete with other listed JAK inhibitors, mainly xeljanz (tofacitinib), to seize market share in the early stage of marketing After that, with the establishment of prescription habits, it is likely that olumiant will surpass TNF inhibitor and become an important treatment drug in the field of rheumatoid arthritis 6 Indications of ribociclib: the sixth blockbuster drug in the cancer (breast cancer) list is ribociclib of Novartis, a highly selective CDK4 / Cdk6 inhibitor In October 2016, the FDA granted the drug a priority review status for the first-line treatment of HR positive and HER2 negative breast cancer The drug was launched in the U.S market in March 2017 (FDA approved the drug on March 13, 2017) The drug is another CDK4 / 6 inhibitor product after Pfizer's ibrance (palbociclib) Ibrance, a strong competitor, was launched in early 2015 Novartis reported the key data of ribociclib in monaleesa-2 trial in October 2016 When the drug was combined with letrozole, the overall response rate (ORR) was 41%, while the orr of single use of trazole was 28% The results of clinical trials show that ribociclib has similar efficacy and characteristics with ibrance, so this new drug may be difficult to replace the position of ibrance To help differentiate drugs, Novartis has launched the monaleesa-7 trial to evaluate the use of ribociclib in combination with tamoxifen and goserellin in premenopausal and perimenopausal women, an indication not covered by other CDK4 / 6 inhibitors under development 7 Avelumab indication: the avelumab of Pfizer is an all human monoclonal antibody against PDL1, which was approved by FDA on March 23, 2017, becoming the first drug for second-line treatment of metastatic Merkel cell carcinoma Clinical trial results show that the remission rate is 31.8% after the use of drugs, which is a potential breakthrough in this challenging disease However, the main indication of avelumab should be ovarian cancer, and it is the first checkpoint inhibitor to enter phase III clinical stage in this indication It is expected that this indication will be the main source of sales of this drug Pfizer is currently conducting the javelin ovarian 200 study of the drug, a phase III study aimed at assessing single drug use and its combination with doxorubicin for platinum resistant / refractory ovarian cancer In May 2016, a phase III study called javelin ovarian 100 was launched to evaluate the use of avelumab as maintenance therapy after the first-line treatment of platinum chemotherapy, or the combination of avelumab and platinum drugs, compared with chemotherapy alone