Which new drugs have been approved by FDA in 2015?

2015 is over Looking back on the past year, FDA's approval process is an unprecedented innovation Throughout the year, the FDA approved about 45 new drugs, including four treatment programs for multiple myeloma, two drugs for heart failure, and other orphan drugs for rare diseases, especially several key vaccines, such as the vaccine for meningitis B, the first seasonal influenza vaccine with adjuvants (mainly for patients over 65 years old), a kind of vaccine to prevent exposure to anthrax Anthrax vaccine in the environment (this is also the first vaccine that has been tested only on animals) There are also innovative medical devices, such as a device to extend the survival of brain cancer patients, a transcatheter pulmonary valve for congenital heart disease without thoracotomy Among them, the most difficult is not only to ensure the quality of high standard work does not decline, but also to increase the flexibility and efficiency of work There is also to pay attention to the voice of patients In recent years, it is necessary to pay attention to the voice of patients in the process of product development Because we should consider the patient's own conditions, the severity of the disease, the choice of treatment options, and of course, we should take a comprehensive view of the problem from the perspective of the caregiver Biological analogue part Five years ago, the U.S Congress authorized the shortening of FDA's approval process for biological product analogues or "substitutes" The purpose of this move is to create a better competitive environment, not only to provide patients with more choices, but also to guide the development of expensive drug substitutes in the market and make the price reasonable Develop next generation sequencing tests and strengthen clinical research The purpose of developing next generation sequencing technology is to use new technology to implement the concept of "precision medicine", and use genetic information to make the treatment more targeted and targeted At the same time, the clinical trial design and optimization of statistical analysis methods are reviewed to meet the requirements of "less patient samples, more accurate results" More highlights Based on the analysis of the new drugs approved in 2015, they can be classified according to the following principles according to certain characteristics: ① more than 1 / 3 of the new drugs are the first of these drugs in classification, that is, the new and unique mechanism of action for the treatment of a specific disease; ② more than 40% of the drugs are used for the treatment of rare diseases with a patient volume of less than 200000; ③ More than 60% of new drug approvals are conducted according to one or more procedures of fast track, breakthrough, priority review or accelerated approval; ④ 64% of new drugs are first marketed in the United States, and the new drugs approved in 2015 are addyi, alecensa, aristada, avycaz, bridion, Cholbam,Corlanor,Cosentyx,Cotellic,Cresemba,Daklinza,Darzalex,Empliciti, Entresto, Farydak,Genvoya,Ibrance, Kanuma,Kengreal,Kybella,Lenvima,Lonsurf,Natpara,Ninlaro,Nucala,Odomzo,Orkambi, Portrazza,Praluent, Praxbind, Repatha,Rexulti,Savaysa,Strensiq, Tagrisso,Tresiba,Unituxin,Uptravi,Varubi,Veltassa,Viberzi, Vraylar,Xuriden,Yondelis, First in class: 16 are new types of innovative drugs, belonging to new mechanism drugs -- addyi, bridion, corlanor, cosentix, darzalex, dupliciti, entresto, ibrance, kanuma, nucala, orkambi, praluent, praxbind, strensiq, unituxin, Xuriden; particularly noteworthy are bridion (neuromuscular blocking effect after reversal surgery anesthesia), ibrance (treatment of advanced breast cancer), praxbind (reversal of adverse anticoagulant effect caused by dabigatran); rare disease drugs: 47% of the drugs approved in this year are rare disease drugs, 21 of which are alecensa, cholbam, cottellic, cresemba, darzalex, Empliciti,Farydak, Kanuma,Lenvima,Natpara,Ninlaro,Orkambi,Portrazza,Praxbind,Repatha*,Strensiq,Tagrisso,Unituxin, Uptravi,Xuriden, Yondelis; kanuma (treatment of lysosomal acid esterase deficiency), orkambi (treatment of pulmonary cystic fibrosis), strensiq (long-acting enzyme substitute for natural or adolescent hypophosphatase), unituxin (treatment of neuroblastoma in children's brain), xuriden (treatment of hereditary lactiuria in patients) This year, in the process of promoting the listing of procedural innovation Fast track: fast track is conducive to promoting the communication between drug R & D personnel and approval personnel, and further accelerating the drug listing Specific drugs include: avycaz, corlanor, cotellic, daklinza, darzalex, entresto, genvoya, kanuma, longsurf, orkambi, portrazza, strensiq, tagrisso, viberzi; breakthrough: this part of work includes all clinical trials to declare that the drug has significant therapeutic effect Such drugs are alecensa, darzalex, dupliciti, ibrance, kanuma, orkambi, praxbind, strensiq, tagrisso, xuriden Priority review: when drugs are considered to greatly improve medical care, a goal is often set to shorten the original 10-month review period to 6 months There are 24 such drugs: alecensa, avycaz, bridion, cholbam, corlanor, cotellic, cresemba, daklnza, darzalex, dupliciti, entresto, farydak, ibrance, kanuma, lenvima, ninlaro, orkambi, praxbind, strensiq, tagrisso, unituxin, viberzi, xuriden, yondelis Accelerated approval: this policy is mainly aimed at those diseases that are extremely life-threatening for patients However, the FDA will still require companies to provide additional materials to support the treatment expectations of the measure Such drugs are alecensa, darzalex, farydak, ibrance, tagrisso, praxbind In the whole approval process, going through a comprehensive accelerated review process can further shorten the time, which means that the time experienced in each link of the whole review period will be shortened in a planned way, which will greatly accelerate the drug's marketing process In this year, there are 27 drugs going through the approval process - alecensa, avycaz, bridion, cholbam, corlanor, cotellic, cresemba, daklinza, darzalex, dupliciti, entresto, farydak, genvoya, ibrance, kanuma, lenvima, lonsurf, ninlaro, orkambi, portrazza, praxbind, strensiq, tagrisso, unituxin, viberzi, xuriden, yondelis Two new antibiotics have been approved - avycaz, cresemba Savaysa, strensiq, Tagrisso,Unituxin,Uptravi,Varubi, Veltassa,Viberzi,Xuriden, Yondelis,Zurampic。 Uriden, Zurampic To sum up, 2015 is a year of innovation for FDA FDA has promoted many reforms internally These reforms have accelerated the speed of drug approval on the basis of not reducing the drug review, not only promoting the drug market for enterprises, but also providing more treatment programs for patients, especially some patients with rare diseases At the same time, with the in-depth reform of FDA and the promotion of the concept of "precision medicine", more drugs will be developed, and problems in current drug development will be continuously optimized, taking more into account the voice of patients, including the benefit risk balance and selectivity of treatment programs, as well as economic factors In general, 2015 is a very important year for pharmaceutical innovation, and in the future 2016, drug approval will continue to expand along the perspective of reform and innovation Source: FDA voice blog