Overview of New Drugs Approved by FDA in September 2014

发布日期:2014-11-17访问次数: 信息来源:ZhangJianzhong字号:[ ]

  In September 2014, two new biologics and one new molecular entity (Table 1) have been approved by FDA, i.e. antineoplastic drug Keytruda (pembrolizumab), antidiabetic agents Trulicity (dulaglutide) and Movantik (naloxegol) for treatment of opioid-induced constipation. There are also a new molecular entity, Otezla (apremilast), approved by FDA for treating moderate and severe plaque psoriasis, which had been approved by FDA for treating active psoriatic arthritis (PsA) in adult patients on March 21, 2014. This drug was described in the Overview of New Drugs Approved by FDA in March 2014, so no repetition will be made here.


Table 1New Drugs Approved by FDA in September 2014

Generic name

Trade name

Formulation/ Specification




Common adverse reactions



Lyophilized powder for injection /50mg

New biologics


For the treatment of melanoma

Fatigue,cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia and diarrhea



Injection /0.75 mg/0.5 mL,1.5 mg/0.5 mL, Preloaded syringes

New biologics

Eli Lilly

For the treatment of type 2 diabetes mellitus

Nausea, diarrhea, vomiting, abdominal pain and decreased appetite



oral tablet/12.5mg、25mg

New molecular entity


For the alleviation of opioid-induced constipation

Abdominal pain, diarrhea, headache and excessive gas in stomach or small intestine area (flatulence).

  Keytruda gained the “Priority Review” and “orphandrug” status and was authorized as Breakthrough Therapy Designation which had accelerated the approval for treating advanced or unresectable melanoma which had no response to other drugs. Keytruda was the first FDA-approved PD-1 blocker, which can bind with the PD-1 (programmed death receptor 1) on T cells, thereby blocking the interaction between PD-1 and PD-L1 or PD-L2 to inhibit the activity of PD-1 and tumor growth. Keytruda is the sixth approved drug for melanoma since 2011. These drugs with different mechanisms of action have brought new choice for melanoma patients. The five drugs approved by FDA since 2011 for treating melanoma are: ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013). The approval of Keytruda was based on the clinical trials that have confirmed the efficacy in 173 patients and the safety in 411 patients with advanced melanoma. The recommended dosage and method of administration of Keytruda is 2mg/kg in every three weeks and intravenous infusion for 30 minutes, until disease progression or unacceptable toxicity. The drug needs to be redissolved and diluted before intravenous infusion.
  Trulicity is a glucagon-like peptide (GLP-1) receptor agonist, and has been approved in combination with diet and exercise to improve glycemic control of adult patients with type 2 diabetes. It is another GLP-1 receptor agonist antidiabetic drug approved by FDA following the liraglutide of Novo Nordisk, exenatide of Bristol-Myers Squibb and AstraZeneca, lixisenatide of Sanofi, and albiglutide of GlaxoSmithKline. In six clinical trials, the safety and efficacy of Trulicity are evaluated in 3,342 patients with type 2 diabetes. The reduction of the glycosylated hemoglobin (HbA1c, an indicator of glycemic control) level was observed in patients receiving Trulicity treatments. Trulicity has a black box warning, indicating that thyroid C-cell tumor has been observed in rodent studies of Trulicity. But it is uncertain whether Trulicity can induce thyroid C-cell tumor in human, including Medullary Thyroid Carcinoma (MTC) in the human body. Trulicity should not be used in patients who have a personal or family disease history of MTC and patients with type II multiple endocrine neoplasia syndrome (the disease that a patient has more than one glands with tumor in the body, which makes it easier for the patient to develop MTC). Trulicity is administered by subcutaneous injection at any time on the day of administration once a week. At the beginning, the drug is administered subcutaneously at 0.75 mg once a week and it can be increased to 1.5mg once a week when there is a need to increase the glycemic control dose. If one injection is omitted, the omitted dose should be administered within 3 days. The method of administration is subcutaneous injection at abdomen, thigh or upper arm, before or after the meal. FDA requires five post-marketing studies of Trulicity to be conducted: one is the clinical trial to evaluate the efficacy and safety in pediatric patients; one is the study to assess the potential effect on sexual maturity, reproductivity and CNS development and function in immature rats; one is at least 15 years register of Medullary Thyroid Carcinoma, to determine whether the Medullary Thyroid Carcinoma incidence is associated with Trulicity; one is the clinical trial to compare the glycemic control by Trulicity and insulin glargine in patients with type II diabetes and moderate or severe renal impairment; one is the cardiovascular outcome trial to assess the cardiovascular risk of Trulicity in patients with high baseline risk of cardiovascular disease. Trulicity was approved by FDA with a risk evaluation and mitigation strategy (REMS) which includes a communication plan to inform healthcare providers of the serious risks associated with Trulicity.


打印本页 关闭窗口
Produced By 大汉网络 大汉版通发布系统