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The strongest resolution! First half of the 2015 FDA approval of 14 kinds of new drugs, biologics accounted for three

The strongest resolution! First half of the 2015 FDA approval of 14 kinds of new drugs, biologics accounted for three

  • Categories:Industry News
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  • Time of issue:2015-08-18 10:35
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(Summary description)2014 US FDA Center for Drug Evaluation and Research (CDER) approved a total of 41 new drugs, a record high since 1996; which, including 11 models of biological agents. Now, 2015 has passed a half, on

The strongest resolution! First half of the 2015 FDA approval of 14 kinds of new drugs, biologics accounted for three

(Summary description)2014 US FDA Center for Drug Evaluation and Research (CDER) approved a total of 41 new drugs, a record high since 1996; which, including 11 models of biological agents. Now, 2015 has passed a half, on

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2015-08-18 10:35
  • Views:
Information

2014 US FDA Center for Drug Evaluation and Research (CDER) approved a total of 41 new drugs, a record high since 1996; which, including 11 models of biological agents. Now, 2015 has passed a half, on the basis of FDA accelerated review, the first half of the pharmaceutical industry, how to harvest it?

According to "Nature Reviews Drug Discovery" Statistics, January 2015 to June a total of 14 drugs approved by the FDA, which has three biological agents, namely the treatment of plaque psoriasis drugs Novartis Secukinumab, NPS Pharmaceuticals treatment of parathyroid gland dysfunction medications Savaysa and United Therapeutics treat neuroblastoma company's new drug Dinutuximab.

The following are the 14 models of drug indications, efficacy and other details of the analysis:

2015 approved by the FDA in the first half of 14 kinds of new drugs

Yuan Rui

Note: with * biologics

Daiichi Sankyo:Savaysa

January 8, the FDA approved the first new drug in 2015 - Daiichi Sankyo Company (Daiichi Sankyo) anticoagulant new drug Savaysa (generic name: according to Medusa class piece, Edoxaban), for reducing non-valvular atrial fibrillation (NVAF) the risk of stroke and systemic embolic events in patients.

FDA-approved according to Medusa based on two main classes listed three positive clinical data. One, code-named ENGAGEAF-TIMI the three clinical recruited 21,105 patients with non-valvular atrial fibrillation, another Hokusai-VTE experiments in the 8292 deep vein thrombosis (DVT) and / or pulmonary embolism (PE) in patients or, head to head comparison of once daily doses of two tablets according to Medusa class and standard warfarin therapy compared the efficacy and safety. Have received the treatment five to ten days anticoagulants (injection or infusion) before these patients. It was found that high doses of classes and methods according to Medusa Waring considerable effect.

Novartis:Cosentyx

Yuan Rui

Opened in 2015, Novartis will be ushered in the opener, the industry's highly anticipated blockbuster monoclonal antibody drugs Cosentyx (secukinumab) scored almost at the same time two major markets in Europe and America. Cosentyx is the world's first interleukin-17 (IL-17) monoclonal antibody, is eligible for EU and FDA approved for the treatment of moderate to severe plaque psoriasis in adult patients (plaque psoriasis). The drug is approved, marking a major milestone in the clinical treatment of psoriasis. In Phase III clinical projects, Cosentyx versus placebo significantly improved skin symptoms, but more effective than the other two blockbuster drugs: Johnson & Johnson's Stelara and Amgen's Enbrel.

NPS Pharmaceuticals:Natpara

Also in January, the FDA announced the approval of NPS developed orphan drug Natpara market. This injectable drugs, primarily by replacing human parathyroid hormone to treat a rare endocrine disorders called hypoparathyroidism. The disease can lead to a lack of calcium and vitamin D synthesis in patients with blocked and eventually include muscle pain, bone problems and other complications. In some acute cases, even lead to the consequences of arrhythmia.

Natpara final approval makes Shire's become the ultimate winner. Shire earlier this year to $ 5.2 billion acquisition of NPS company to expand its strength in research of rare diseases. Today, NPS has proved this since its acquisition value for money

Pfizer:Ibrance

3 February, Pfizer announced that its new drug Ibrance breast cancer has been accelerated FDA approval, is the world's first listing of CDK4 / 6 inhibitors. Ibrance is an oral cyclin-dependent kinases 4 and 6 inhibitor in combination with letrozole as initial endocrine therapy-based program for the treatment of ER + / HER2- postmenopausal women with advanced breast cancer.

Pfizer CEO Ian Read Ibrance line represents the second quarter market share of 22 percent, more than double just listed the first quarter. In Ibrance driven Pfizer antineoplastic overall sales will rise 36%. Analysts predict Ibrance second-quarter sales will reach $ 72 million, but the actual sales of $ 140 million. Pfizer also plans to carry out other experiments, the researchers Ibrance efficacy in the treatment of complex disorders. For example, Pfizer is studying the effects of cancer therapy Ibrance for head and neck cancer and human papillomavirus irrelevant.

Eisai:Lenvima

In early February this year by the Japanese pharmaceutical Eisai (Eisai) independent research and development of new anti-cancer drugs Lenvima (lenvatinib) approved by the FDA for the treatment of radioactive iodine-refractory differentiated thyroid cancer (RR-DTC) patients.

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor, having a novel binding mode, in addition to inhibiting the proliferation of other pro involved in tumor angiogenesis and oncogenic RTK signaling pathway, but also capable of selectively inhibiting the vascular endothelial growth factor (VEGF) receptor kinase activity.

Lenvatinib approved, is based on a positive top line Phase III study data SELECT. The study was a multicenter, randomized, double-blind, placebo-controlled study investigated the oral lenvatinib (24mg) of radioactive iodine 131 treatment resistant differentiated thyroid cancer (RR-DTC) effect. Data show that, compared with placebo, lenvatinib make progression-free survival (PFS) was significantly longer statistically significant (18.3 months vs 3.6 months, p & lt; 0.0001), in addition lenvatinib treatment group, 65% of cancer patients narrow, only 2% of the placebo group data, met its primary endpoint of the study.

Recently, Lenvima treatment of renal cell carcinoma (RCC) came the good news in the US regulation, FDA has granted Lenvima the treatment of advanced and / or metastatic renal cell carcinoma (RCC) of breakthrough drugs qualifications (BTD). Currently, Eisai is also being evaluated lenvatinib used for other types of cancer treatment, including liver cancer (III clinical), endometrial cancer (II clinical), non-small cell lung cancer (II clinical) and the like.

Novartis:Farydak

February 23, the FDA approved a Novartis HDAC inhibitors Farydak (generic name: panobinostat) listed for bortezomib and dexamethasone in combination, have received prior treatment with bortezomib and an immunomodulatory therapy but the recurrence of multiple myeloma. Farydak is the first approved by the FDA for the treatment of multiple myeloma HDAC inhibitors.

It supports the FDA decision is primarily a 193 positive clinical results contain subjects participated. All of these patients had received at least prior bortezomib and an immunomodulatory agent is treated, but patients with multiple myeloma relapse. In this experiment, Farydak / bortezomib / dexamethasone treatment group and the triple combination bortezomib / dexamethasone combination bivalent compared to the control group, progression-free survival (PFS) from 5.8 months in the control group was extended to 10.6 months of triple combination therapy group. Response rates increased from 41 percent to 59 percent in the control group of the triple combination.

Al built:Avycaz

Yuan Rui

February 25, Actavis (Actavis, after the acquisition of Al built more 名艾尔 construction) announced new antibiotics Avycaz product approved by the FDA for the complexity of the inner abdominal infections (cIAI) (metronidazole) and complicated urinary tract infections (cUTI) treatment.

Avycaz (ceftazidime-avibactam, ceftazidime - Avi TAZ) is a broad-spectrum cephalosporin (ceftazidime) and a novel & beta; - lactamase inhibitor (avibactam) consisting of combination products, developed for the treatment of leather Gram-negative bacterial infections, including existing antibiotic resistance to a broad spectrum of products & beta; - lactam enzyme Klebsiella pneumoniae carbapenemase.

Avycaz originally from Forest Laboratories (Forest Lab) and AstraZeneca joint development, but in February last year, Actavis cost $ 25 billion acquisition of Forest Lab will Avycaz bag. Under the agreement, Actavis has the right Avycaz in the North American market, AstraZeneca has the right Avycaz in other regions of the world.

Astellas Pharma:Cresemba

3, FDA on Friday approved a Japanese Astellas (Astellas Pharma) a broad-spectrum antifungal Cresemba (isavuconazonium, 艾沙康 yl), the drug is mainly used in the treatment of invasive aspergillosis and mucormycosis, two fungal infections, mainly in leukemia patients.

Clinical trial data sheet Mingaishakang azole is safe and effective, compared with voriconazole (Pfizer's antifungal drug, trade name Vfend), lower patient mortality. Cresemba also received FDA QICP (Qualified Infectious Disease Product) certification, this certification is designed to encourage research and development in the field of infectious diseases antibiotics to reduce bacterial or fungal infections.

United Therapeutics:Unituxin

March 10, FDA approved the company United Therapeutics Unituxin (generic name: dinutuximab) listed as second-line therapy for a rare form of cancer occurs mainly in children & mdash; neuroblastoma (neuroblastoma). At the same time the FDA approved Unituxin company United Therapeutics also awarded a rare pediatric diseases priority review lottery.

Unituxin is a capable and neuroblastoma cell surface binding of the antibody. Clinical trials support the efficacy and safety of Unituxin recruited 226 cases of high-risk neuroblastoma in pediatric patients. These subjects were randomly divided into two groups, one group was treated with vitamin A medication isotretinoin (control group), another group infused Unituxin and interleukin-2, granulocyte - macrophage colony stimulating factor (MG-CSF), and isotretinoin (combination group). And too many of these patients have previously received combination chemotherapy, surgery, intensive chemotherapy, bone marrow transplantation, and radiation therapy, and at least a partial response performance. The results showed that after three years Unituxin combined group 63% of cancer patients does not increase or recurrence, higher than the control group 46% isotretinoin (updated data 73% and 58%, respectively).

Retrophin:Cholbam

March 17, FDA approved the company's Cholbam Retrophin capsules. It is approved by the FDA due to lack of a single enzyme for bile acid synthesis disorders caused by pediatric and adult patients and for peroxisome disease (including Zellweger spectrum disorder) in patients with the first treatment. Cholbam as an oral therapy approved for children and adult patients for three weeks and older.

Amgen:Corlanor

In mid-April, Amgen announced, the company developed a heart medication ivabradine (Corlanor) has received approval from the FDA, which is currently the world's first to reduce the heart rate and hospitalization rate for heart disease in patients with new heart drugs.

Date Ivabradine last fall won FDA approval of the Committee of Experts, FDA the drug to make the final decision as early as in the original plan. This conclusion is mainly in the company has submitted a 6500 baseline clinical research on heart patients participate made. In this study, compared to placebo, ivabradine successfully delayed due to heart disease patients and time to first hospitalization.

However, despite ivabradine get the American identity, but this drug on the European market has caused a sort of controversy. Because last year in Europe Amgen conducted a three-month clinical study on coronary artery disease, although patients successfully reduced the number of beats per minute 10 times, but failed to produce in heart disease mortality and the control group significant differences.

Kythera:Kybella

Yuan Rui

4, FDA approved two weeks in advance of the world's first "double chin" fat dissolving needle Kybella (ATX-101), for moderate to severe "double chin" adult, the injection is used to eliminate excess fat under the chin (double chin) is the first and only non-surgical therapy products. ATX-101 is an artificial deoxycholate (deoxycholic acid), which is a naturally occurring substance in the human body to help break down fats. In clinical trials, when compared to placebo, ATX-101 can effectively eliminate fat under the chin and improve the overall appearance. The approval, so that ATX-101 becomes similar products first approved injections for cosmetic purposes.

Kybella market, will be "double chin" groups to provide a high-quality non-surgical treatment option for most patients injected 2-4 times, you can get satisfactory results, some patients may require less injected six times. But note that any cell can be destroyed due deoxycholate come into contact, FDA only approved Kybella for submental area adipose tissue, it is prohibited for other sites.

According to the American Society for Dermatologic Surgery (ASDS) estimates that about 68 percent of Americans by the "double chin" troubled. Kybella beauty industry as a truly innovative product, the market potential is considerable. The industry is expected, Kybella peak annual sales will exceed $ 300 million. In June, the first to see the value of Al Kin Kybella to $ 2.1 billion acquisition of Kythera.

Actavis: Viberzi

May, FDA approved generic drug manufacturers Actavis Switzerland (Actavis) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) of new drugs Viberzi (eluxadoline). Viberzi originally developed by the Furiex company, Forest Laboratories (Forest Lab) in July 2014 will cost $ 1.47 billion acquisition of Furiex company; later, Actavis has a cost of $ 25 billion acquisition of the Forest Lab, will Viberzi bag.

Viberzi is a first effective oral, locally acting drugs, has a unique mechanism of action; the drug has a mixed opioid receptor activity, is the μ receptor antagonists, also delta receptor agonists and kappa receptor agonist agent. In the two Phase III clinical compared to placebo Viberzi can significantly reduce abdominal pain and diarrhea IBS-D patients. However, the drug also has certain serious side effects, including pancreatitis.

The Medicines Company: Kengreal

June 23, FDA approved antiplatelet Medicine's Company Listed cangrelor injection (trade name: Kengreal), in adult patients for preventing coronary artery after percutaneous coronary intervention (percutaneous coronary intervention, PCI) process due to clotting caused blocked.

And other anti-platelet drugs, the most serious risk Kengreal is bleeding, sometimes even life-threatening. In a head to head comparison of more than 10,000 people involved in Kengreal and Plavix (clopidogrel) in clinical trials, Kengreal and clopidogrel compared to more significantly reduce the incidence of myocardial infarction, although severe bleeding in both groups event rates are relatively low, but Kengreal group (1/170) than in the clopidogrel group (1/275).

Cangrelor is reversible P2Y12 inhibitor. First developed by a small British company, after the acquisition of AstraZeneca. 2003 Medicine's Company from the hands of AstraZeneca's acquisition of development rights Cangrelor. RBC Capital Market analyst Adnan Butt Cangrelor in the United States is expected to peak sales of about 8 from 10 million to 100 million US dollars.

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