FDA new drug approval list in November 2015

In the penultimate month of 2015, FDA approved another batch of drugs, among which biological products are the largest Among them: 1 November 4, 2015: nucala (mepolizumab) FDA approved the use of nucala as a synergistic therapeutic agent for existing asthma drugs The drug will be used in patients over the age of 12 with a history of severe asthma attacks This drug is mainly used as a supplement of existing asthma drugs, and provides a new supplementary program for extremely serious asthma diseases This is a monoclonal antibody of human interleukin-5 antagonist produced by DNA recombination technology The drug slows down the onset of asthma by lowering the level of eosinophils The drug is marketed by GlaxoSmithKline 2 November 5, 2015: genvoya FDA approved the use of genvoya in the treatment of type 1 HIV patients over 12 years old Genvoya is a new prescription drug composed of elvitegravir, cobicistat, emtricitabine, and tenofoviralafenamide Genvoya was launched by Gilead The relatively serious side effects of the drug are excessive accumulation of lactic acid in the blood and relatively serious liver toxicity The most common side effect is nausea 3 November 10, 2015: cotellic (cobimetinib) FDA approved the use of cotellic (cobimetinib) as part of the combined treatment of advanced metastatic melanoma As a blocker of MEK enzyme, cotellic can work together with other BRAF inhibitors Serious side effects of the drug include cardiomyopathy, rhabdomyolysis, primary malignant tumor, retinal detachment and so on The drug is mainly launched by Genentech 4 November 13, 2015: tagrisso (osimertinib) tablet FDA approved the use of tagrisso in EGFR mutation (T790M) caused by non-small cell lung cancer (NSCLC) and EGFR blocking treatment still ineffective cancer treatment The most common side effects of the drug are diarrhea, dry skin, and rash infections and redness around the nails The drug is a rapidly approved orphan drug launched by AstraZeneca 5 November 13, 2015: adynovate FDA approved the use of adynovate for the treatment of hemophilia A type A Adynovate is a new drug obtained by modifying the anti hemophilia factor The advantage of adynovate compared with the unmodified anti hemophilia factor is that it has lower injection frequency and longer onset time Adynovate is a PEGylated whole length agglutination factor VIII After PEG treatment, the effective time is longer The drug was launched by baxaltaus 6 November 16, 2015: darzalex (dartaumab) is approved by the FDA to be used for the treatment of multiple myeloma, mainly for the situation that the efficacy is not good after receiving at least three treatment schemes before It is the first monoclonal antibody for multiple myeloma The drug is a priority and rapid approval orphan drug launched by Janssen biotech 7 November 18, 2015: narcannalspreay (naloxone hydrochloride) was approved by the FDA for reversal therapy of opioid overdose Overdose of opioids can lead to death in many cases Common opioid intake such as oxycodone, dihydrocodeine and morphine When ingested excessively, it will appear the symptoms of deep sleep, weakened breathing to stop If the reversal agent can be taken in time, it will recover within 2 minutes The drug is a new preparation launched by adaptpharma, which has been approved by the rapid approval process 8 November 20, 2015: ninlaro (ixazomib) FDA approved the combination of ninlaro (ixazomib) and other drugs in the treatment of multiple myeloma Patients with this drug have received at least one previous pre-treatment Ninlaro (ixazomib) is the first oral proteasome inhibitor, which is usually used in combination with Revlimid (lenalidomide) and dexamethasone to treat myeloma The drug is an orphan drug which is first authorized by FDA 9 November 23, 2015: opdivo (nivolumab) is approved by FDA for the treatment of advanced renal cell carcinoma The drug has previously been approved by FDA as a treatment for non-small cell lung cancer expressing PD-1, and this authorization is mainly aimed at the expansion of its scope of application Therefore, the pharmacological effect of the drug is still a blocker of PD-1 metabolic pathway The drug is mainly suitable for patients who have received anti Angiotension treatment before It is a very important immune drug in immunotherapy The drug was launched by Bristol Myers Squibb 10 Nov 23, 2015: biothrax (anthaxvaccineadsorbed) FDA approved biothrax (anthaxvaccineadsorbed) as the prevention of confirmed or suspected personnel exposed to the environment containing Bacillus anthracis In fact, as early as 1970, the drug has been used to prevent such exposure risks This authorization is mainly aimed at its application as a new type of inhaler The specific development company of the drug is emergentbiodefense operations Lansing November 24, 2015: the FDA of portrazza (necitumumab) approved portrazza (necitumumab) as a treatment for advanced squamous non-small cell lung cancer The drug is a monoclonal antibody that blocks EGFR The most common side effects of the drug are skin redness and hypomagnesemia The drug was introduced by Lilly November 24, 2015: fluad, a seasonal influenza vaccine containing adjuvant, is approved by the FDA for influenza prevention in the elderly aged 65 and over Fluad is the first seasonal influenza vaccine containing adjuvants It is prepared from three strains of influenza virus (two A subtypes and one B type) The squalene oil emulsion (oil in water) is used as an adjuvant The drug was approved through the rapid approval process In Italy, Europe, the drug was launched in 1997, and then successively in 37 countries Relatively speaking, the risk will be much smaller The drug was launched by Novartis vaccine and diagnostics 13 November 30, 2015: dupliciti (elotuzumab) is approved by the FDA as a recommended component for the combination of multiple myeloma Dupliciti can activate the immune system to kill cancer cells, but it usually needs to be combined with Revlimid and dexamethasone to achieve this effect The drug was launched by Bristol Myers Squibb For more news, please pay attention to yaozhi.com.