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    Home > Active Ingredient News > Drugs Articles > "Bombshell" potential! 12 new drugs worth watching this year

    "Bombshell" potential! 12 new drugs worth watching this year

    • Last Update: 2018-04-19
    • Source: Internet
    • Author: User
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    Source: the latest report "the most noteworthy drug forecast 2018" released by pharmaceutical economic daily April 19, 2018, forecasts 12 blockbuster new drugs that will be launched in 2018 (already or likely to be launched), and the sales of these new drugs will reach the blockbuster level within 5 years More than half of the 12 drugs have been identified by priority review, breakthrough therapy or fast track review, among which 5 are first inclass new drugs, 4 are orphan drugs, and only one anti-tumor drug has been listed, namely, J & J's erlada (aplutamide) 1 The emergence of clotting factor Ⅷ inhibitor, the future leader of hemophilia market, is the most serious and challenging complication in hemophilia treatment Hemlibra has been approved for haemorrhage prevention in children or adults with factor Ⅷ inhibitors to prevent or reduce the occurrence of haemorrhagic events The approval of the drug has brought the first new treatment for the disease in 20 years At present, other drugs available in the field are mainly FEIBA (prothrombin complex) of shire and novo seven (recombinant coagulation factor ⅶ a) of nordenod In fact, the time limit for the FDA to make an approval decision on hemlibra is February 2018, but due to priority review, breakthrough therapy and orphan drug certification, the FDA approved hemlibra in advance in November 2017 In any case, hemlibra is one of the most interesting new drugs in 2018, because the sales and promotion of the product will be fully launched in 2018, and it will be approved for marketing in more countries In February 2018, the European Drug Administration (EMA) approved hemlibra The product is expected to enter the European Union and Japan markets at the same time in the year The sales volume is expected to reach 496 million dollars in 2018, 1457 million dollars in 2019 and 402 million dollars in 2022 After 2018, FEIBA and NovoSeven are likely to see a significant decline in sales due to hemlibra's competition The biggest impact is that hemlibra will be approved for use in hemophilia A without limiting factor Ⅷ inhibitor, which will greatly expand its scope of use The new mechanism of action, excellent efficacy and potential once a month administration frequency of hemlibra will have a huge impact on the market pattern of factor Ⅷ Despite the black box warning (FDA's serious warning of potential serious adverse reactions) about the risk of thrombosis, hemlibra will still lead the hemophilia treatment market beyond 2020 2 Biktarvy and GSK products seize the HIV market Biktarvy is a compound preparation containing a new integrase inhibitor, bitegravir, a nucleoside reverse transcriptase inhibitor, tenofovir and enrutabine It was approved in the United States in mid February 2018 and quickly launched on the market The fight between Gilead and GSK in the anti HIV market is fierce In 2014, GSK launched triumeq, whose success brought it back to the anti HIV market In response, Geely has launched several best combination solutions with better security, including genvoya launched in 2015, odefsey and descent launched in 2016, which help Geely regain its lost market share In January 2018, GSK launched dulutway / ribavirin, which is the best combination of tivicay (dulutway) and ribavirin Biocegravir is as safe and effective as tivicay, and is a real once a day integrase inhibitor as tivicay, without any additional enhancers With the generic drugs of tenofovir ester coming into the market in December 2017, the generic drugs of Atripla and truvada are also expected to come into the market in the near future Moreover, the market share of GSK based on tivicay therapy is still increasing, and Gilead is likely to fully promote biktarvy Biktarvy's sales are expected to reach US $896 million in 2018, rapidly rise to US $2.282 billion in 2019 and US $3.716 billion in 2022 3 The competitiveness of ozempic needs to be fully explored Ozempic, a GLP-1 analogue administered once a week by Novo Nordisk, was approved for the treatment of type 2 diabetes in December 2017 and launched in February 2018 The market share of once daily administration of norholide is gradually losing, while the market share of once weekly administration of GLP-1 analogues is gradually increasing, especially the trulicity of Lilly However, according to the published data of sustain 7 in 2017, ozempic's hypoglycemic effect and weight reduction effect are better than that of trulicity Rewind, a clinical trial to gather evidence of trulicity's cardiovascular benefits, is still underway and data are expected to be made public in 2018 Because ozempic has obtained positive evidence of cardiovascular benefits, it will press on trulicity to help Novo Nordisk regain GLP-1 market share Nevertheless, trulicity will remain the leader in the GLP-1 market in 2022, with forecast sales of $4099 million, Novelli of $3912 million and ozempic of $3469 million GLP-1 analogs administered by injection are usually used when oral hypoglycemic agents do not control blood glucose, but once daily oral somalutide (in the pioneer project evaluation) will change the "rules of the game" of type 2 diabetes treatment Oral GLP-1 can replace small molecule hypoglycemic drugs at an earlier stage of treatment, which can not only reduce blood sugar more effectively, but also benefit cardiovascular system In addition, somaluptide is also carrying out clinical research on obesity and non-alcoholic fatty liver (NASH), which will pose a threat to competitive products in an all-round way 4 Erlada's first mover advantage drives sales growth The castration resistant prostate cancer (CRPC) market is dominated by Johnson & Johnson's new generation of oral androgen drugs zytiga (abitron) and antandi (enzalutamide) of anstar / Pfizer However, both products are only approved for metastatic CRPC Erlada (R & D of Johnson & Johnson), the second generation of new antiandrogen drug approved in mid February 2018, took the lead and became the first therapy in the field of non metastatic CRPC Xtandi has shown positive data in clinical trials (prosper) for non metastatic CRPC, and has submitted an application for listing of this indication to FDA Still, erlada has a first mover advantage, entering the U.S market shortly after its approval, with sales expected to reach the blockbuster level by 2020 In addition to non metastatic CRPC, erlada has the potential to be approved for other indications, including metastatic hormone sensitive prostate cancer (Titan test), locally high-risk / locally advanced prostate cancer (atlas test) and the combination of abiolone in the treatment of non chemotherapy metastatic CRPC, which will be the driving force for its rapid growth in sales 5 After two years of approval from FDA in October 2017, the shinglix (recombinant herpes zoster vaccine, adjuvant) of GSK will be put on the market in early 2018 It is the first new type of herpes zoster vaccine in more than ten years Zostavax of mosadong is the only approved herpes zoster vaccine by FDA The prevention effect of Zostavax will gradually decline over time, while shingrix can provide continuous protection, and it is still effective for Zostavax to prevent failure population Although only one dose of Zostavax and two doses of shinglix are needed, the Centers for Disease Control and prevention in the United States officially recommended the use of shinglix for vaccination of people over 50 years old in January 2018 Within two years after its launch, shingrix is expected to replace Zostavax as the market leader of herpes zoster vaccine It is estimated that shingrix's sales will reach 537 million US dollars in 2019, while Zostavax's sales will drop to 492 million US dollars from 765 million US dollars (peak) in 2014 In addition, shinglix's sales will exceed $1 billion after 2021 6 Patisiran is expected to become the first RNAi drug in the United States to apply for the indication of hereditary PTH related amyloidosis If it is approved successfully, it will become the first RNA interference drug (RNAi) in the United States Prior to this, FDA has granted patisiran priority review, fast track and breakthrough therapy identification, and PDUFA period is August 2018 On the European side, EMA has awarded paisiran the qualification for accelerated review The product is expected to be launched in the United States and Europe at the same time by the end of 2018, becoming the standard therapy for hereditary PTH related amyloidosis At present, the standard therapy for this disease is liver transplantation, but this therapy has the risks of operation, acute liver rejection, infection, high requirements for clinical conditions, and only for patients who can receive intervention Pfizer's vyndaqel (tafamidis) is the first anti amyloidosis drug, but it is only approved for familial amyloid polyneuropathy at present Moreover, the product is only used in the early stage of disease, and has not been approved for marketing in the United States 7 Epidilex (plant extracted cannabis diphenol) is expected to become the first antiepileptic drug containing cannabis diphenol by building GW pharmaceutical, a medical template of cannabis extract FDA has granted it the priority review qualification, and PDUFA period is June 2018 In addition, the European listing application (MAA) has also been submitted Because epidiolex is very persuasive to the data of Dravet syndrome and Lennox Gastaut, the probability of approval is very high Although epidiolex may be approved for listing, there are still policy barriers to sales This barrier limits the use of all marijuana extraction drugs, particularly in the United States, where there are strict guidelines for their use Nevertheless, epidilex's annual sales are expected to reach $1191 million by 2022 Epidiolex is very promising, it can pave the way for the medical use of cannabis extract 8 Aimovig (erenumab), which is the key to the speed of listing of aimovig, may become the first CGRP inhibitor to be listed Getting the first listing right is crucial for Aimovig, as competition is coming from two mAbs of the same target Lilly's galcanezumab (once a month) and TIWA's freeezumab (once a month or once every three months) have submitted listing applications to FDA Alder's eptinezumab (once every 3 months) is still in phase III clinical trials, but the response rate in some patients is as high as 100% The product is expected to be put on the market in 2018 Aimovig is expected to become the "leader" in the CGRP inhibitor market, with the predicted sales volume of US $1170 million in 2022; freemanezumab ranks second with the advantage of one injection in March, with the predicted sales volume of US $999 million; galcanezumab ranks third, with the predicted sales volume of US $546 million; eptinezumab follows, with the predicted sales volume of US $368 million Because of the strong clinical data, the sales of eptinezumab will increase rapidly, and it is expected to reach 946 million US dollars in 2023 It is worth noting that there will be competition for oral CGRP inhibitors in the future, such as atogepant of Elgin and rimegepant of biohaven Because of the advantages of oral administration, these products will take a large share of the market 9 Lanadelumab's multiple competitive advantages have helped sell the new genetic angioedema drug lanadelumab of shire, and its application for listing has been submitted, and it has obtained the priority review in the United States and the accelerated review qualification in the European Union Cinryze (human complement C1 esterase inhibitor) is the main product to prevent angioedema at present, but the main disadvantage is that it needs intravenous injection The first subcutaneous product is haegarda, a complement C1 esterase inhibitor approved for marketing by CLS belline in 2017 Despite its first advantages, lanadelumab will still take the lead
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