In December, the 9 new drugs will receive FDA review results

Source: Wuxi apptec is approaching the end of 2017-12-04, and the biomedical industry and the U.S FDA will have another busy December So far, 40 drugs have been approved this year, compared with a record of 46 in 2015 At present, nine companies are waiting for the FDA's review decision in December Next, let's look at 9 new drugs that FDA is expected to announce in December! Name of new drug: repatha for disease: pain R & D company: Amgen PDUFA date: December 2, Amgen is waiting for the decision of repatha supplement biologics licensing application (SBLA), including the ability of the drug to reduce the occurrence of major adverse cardiovascular reactions The drug was originally approved for the treatment of high cholesterol, but further research is needed to show that it also actually reduces the risk of heart disease, angina, stroke or related adverse reactions Repatha ® is an injection prescription drug called PCSK9 inhibitor When used in adults with heterozygous familial hypercholesterolemia (a genetic disease leading to high levels of LDL) or atherosclerotic heart disease or vascular problems, diet and the treatment of the most tolerable statins are needed, and LDL cholesterol needs to be reduced additionally Name of new drug: myl-1401o for disease: breast cancer R & D company: mylan PDUFA date: December 3, the company is seeking FDA approval of its biological preparation license application (BLA) of myl-1401o, a new biological similar drug of Roche Herceptin (used to treat breast cancer) The bio similar drug was jointly developed by mylan and biocon, and was unanimously approved by the FDA Cancer Drug Advisory Committee in July The PDUFA date of the application is December 3 (related reading: the first Herceptin bio similar drug was approved today to treat gastric cancer and breast cancer) Myl-14010 is a biological analogue of trastuzumab (Herceptin) for the treatment of some HER2 positive breast cancer Name of new drug: semaglutide for disease: type 2 diabetes R & D company: Novo Nordisk PDUFA date: December 5, Novo Nordisk expects FDA to approve its weekly application for semaglutide (somalutide) for type 2 diabetes on December 5 The new drug is a glucagon like peptide-1 (GLP-1) receptor agonist with the same mechanism as truclicity In a one-on-one trial of semaglutide and trulicity, semaglutide showed a better reduction in HbA1c and weight than the weekly trulicity Semaglutide is a new long-acting glucagon like peptide-1 (GLP-1) analogue Subcutaneous injection once a week can significantly improve the blood glucose level of type 2 diabetic patients and reduce the risk of hypoglycemia At the same time, semaglutide can also induce weight loss by reducing appetite and food intake Name of new drug: a-101 40% local solution for disease: seborrheic keratosis R & D company: aclaris therapeutics company PDUFA date: December 24 US FDA will decide on December 24 aclaris company's new drug application for a-101 40% local drug for seborrheic keratosis The compound is designed to penetrate into seborrheic keratosis (SK) lesions and cause oxidative damage, which can cause SK cells to fall off A-101 40% topical solution is a drug under development, which is a high concentration hydrogen peroxide preparation for the treatment of seborrheic keratosis (SK) A-101 is specially designed for external use management of clinic treatment It is equipped with a patented pen applicator, which is convenient for local application and ensures the stability of the product New drug name: twirla for disease: hormone contraceptive R & D company: agile therapeutics company PDUFA date: December 26, twirla of agile company is a low-dose combined hormone contraceptive patch The FDA rejected the drug's application in 2013, asking agile to conduct a new clinical trial and provide more information about the manufacturing process As a result, agile conducted a phase 3 clinical trial named secure in 2032 healthy women in 102 locations in the United States The PDUFA date of the application is December 26 Twirla ®, also known as ag200-15, is a weekly clinical prescription contraceptive patch Twirla ® is a combined hormonal contraceptive or CHC patch containing the active ingredient ethinylestradiol or EE, which is a synthetic estrogen, levonorgestrel or LNG is a progesterone, a synthetic steroid hormone, both of which have definite effectiveness and safety in the combination of low-dose oral contraceptives currently on sale Name of new drug: luminesse for disease: red eye R & D company: Valeant pharmaceuticals international company PDUFA date: December 27 Bausch + Lomb, a subsidiary of Valeant company, is expected to approve the new drug application of its luminesse product by FDA on December 27 The drug is an over-the-counter eyedrop used to treat redness of the eyes caused by mild eye irritation The active ingredient of luminesse is bromonidine tartrate If approved, it would be the first over-the-counter treatment for eye redness with bromonidine tartrate New drug name: macrilen for disease: adult growth hormone deficiency research and development company: aeterna zentaris PDUFA date: December 30 macrilen is an oral active auxin releasing peptide agonist used to evaluate adult growth hormone deficiency The US FDA rejected its application in 2014 because it did not meet the required main clinical indicators The FDA asked the company to conduct a new confirmatory clinical trial using insulin tolerance test (ITT) to assess the condition of adult growth hormone deficiency in order to verify macrilen The results of the validation test are not equivalent to the ITT test, which was used as a way to diagnose AGHD in January 2017, but the company resubmitted the new drug application in June The PDUFA date of the application is December 30 Compared with ITT, macrilen Gamma Stimulating the pituitary gland to produce growth hormone is more effective; in about 80% of patients, the level of growth hormone measured after the application of macrilen is equal to or higher than the level of growth hormone produced by ITT New drug name: xeljanz for disease: psoriatic arthritis R & D company: Pfizer PDUFA date: December, xeljanz 5 mg and xeljanz xr11 mg of Pfizer are suitable for adults with psoriatic arthritis The PDUFA date for the SNDA is expected to be in December Xeljanz is a fast-release tablet taken twice a day and xeljanz XR once a day They are all on the market for moderate to severe active rheumatoid arthritis in adults Xeljanz is a Janus kinase (JAK) inhibitor, which destroys the activity of signal pathway in cells These JAK pathways play a role in RA related inflammation Pfizer is also seeking to expand its approval of bosulif to include first-line treatment for chronic Philadelphia chromosome positive (Ph +) chronic myeloid leukemia (CML) The drug has been approved for use in adults with previously resistant or resistant Ph + CML treatments New drug name: ertugliflozin for disease: type 2 diabetes R & D company: MSD and Pfizer PDUFA date: December, these two companies provide three new ertugliflozin new drug applications for adults with type 2 diabetes They are seeking FDA approval for Pfizer's ertugliflozin as a monotherapy and a fixed dose combination with januvia and metformin from mosadon In clinical trials, data have shown a significant reduction in A1C over a period of 2 to 3 months in patients taking metformin or the first co administration with januvia Ertugliflozin is a sodium glucose cotransporter-2 (SGLT2) inhibitor that helps improve blood glucose control in adults with type 2 diabetes.