New Drug Approvals - The Month That Was

(RTTNews) - Another month has come to a close, and here we bring you a list of new drugs that passed muster with the FDA in February.

Ibrance - for the treatment of postmenopausal women with advanced (metastatic) breast cancer was granted accelerated approval on February 3, 2015. The drug is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.

Developed by Pfizer Inc. (PFE), Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. This drug is the first CDK 4/6 inhibitor to be approved by the FDA, and is available to order through select specialty pharmacies.

The most common adverse reactions associated with Ibrance include neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis, according to the product label.

Given the fact that Ibrance has been approved under accelerated approval based on progression-free survival, continued approval may be contingent upon verification and description of clinical benefit in a phase III confirmatory trial, dubbed PALOMA-2.

Dutrebis - for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients greater than or equal to 6 years of age weighing at least 30 kg was approved by the FDA on February 6, 2015.

Developed by Merck Pharmaceuticals, Dutrebis is a fixed dose combination tablet containing 150 mg of Lamivudine and 300 mg of Raltegravir. Lamivudine works by blocking HIV from reproducing while Raltegravir works by blocking HIV-1 integrase, an enzyme needed for the HIV virus to replicate.

The most common side effects observed during treatment with the individual components of Dutrebis are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhoea and cough.

Dutrebis will not be made commercially available in the U.S. at this time, according to the company.

On January 22, 2015, Dutrebis was recommended for European approval by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Lenvima - to treat patients with a type of thyroid cancer known as differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy was approved by the FDA on February 13, 2015, approximately two months ahead of the decision date of April 14, 2015.

Differentiated thyroid cancer is the most common form of thyroid cancer and is said to account for approximately 95% of all thyroid cancers.

In clinical trials, Lenvima-treated participants lived a median of 18.3 months without their disease progressing compared to a median of 3.6 months for participants who received a placebo. Additionally, 65% of participants treated with Lenvima saw a reduction in tumor size, compared to 2% of participants who received a placebo.

Developed by Eisai Co., Ltd. Lenvima works by works blocking certain proteins like VEGFR, FGFR and also RET from helping cancer cells grow and divide. The drug is available through two specialty pharmacies, Accredo and Biologics Inc.

Lenvima is under regulatory review in Japan and the EU, as well as Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.

The serious side effects associated with Lenvima include cardiac failure, blood clot formation, liver damage, kidney damage and changes in the heart's electrical activity (QT Interval Prolongation), to name a few.

Farydak - for the treatment of multiple myeloma was granted accelerated approval by the FDA on February 23, 2015. The drug is to be used in combination with Velcade and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior treatment regimens.

Developed by Novartis (NVS), Farydak works by inhibiting histone deacetylase enzymes that play a role in the development and progression of cancer.

In clinical trials, the median progression-free survival in Farydak-treated patients who had received prior treatments was 10.6 months compared to 5.8 months in the placebo arm.

Since Farydak is approved under accelerated approval based on progression-free survival, continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Farydak can cause fatal and serious toxicities including severe diarrhea and cardiac toxicities and the FDA has approved a *risk evaluation and mitigation strategy, or REMS, for the drug. *REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product.

Regulatory applications for Farydak are underway in the EU, Japan and worldwide.

Avycaz - to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options was approved by the FDA on February 25, 2015.

Owned by Actavis plc (ACT), Avycaz is a fixed-combination drug containing Ceftazidime, an approved antibiotic, and Avibactam, a new beta-lactamase inhibitor.

Avycaz works by inhibiting a broad range of ß- lactamases, including Class A (Extended-Spectrum ß-Lactamases and Klebsiella pneumoniae carbapenemase), Class C (AmpC) and some class D enzymes produced by Gram-negative pathogens that are encountered in the hospital setting and involved in some of the most serious infections like cIAI and cUTI.

Avycaz, approved as a Qualified Infectious Disease Product, will be available in the second quarter of 2015, according to Actavis. The QIDP designation makes AVYCAZ eligible for a five-year regulatory extension of exclusivity under the Hatch-Waxman Act.

Toujeo - a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes, was approved by the FDA on February 25, 2015.

Developed by Sanofi (SNY), Toujeo is a long-acting insulin for the control of high blood sugar, which is to be taken once a day at the same time each day.

In clinical trials, Toujeo demonstrated similar blood sugar control as compared to Lantus, which is also from Sanofi's stable.

Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 units of Toujeo and requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus SoloSTAR, according to Sanofi.

The company expects to launch Toujeo in the U.S. at the beginning of Q2 2015. Toujeo is currently pending marketing authorization with the European Medicines Agency and other health authorities around the world.

Levosert - a hormonal intrauterine contraceptive for use by women to prevent pregnancy for up to three years was approved by the FDA on February 27, 2015.

In what is perhaps the largest intrauterine device trial, Liletta was found to be 99.45% effective in preventing pregnancy in women regardless of age, parity (previous births), or BMI. The trial is ongoing to evaluate the use of Liletta for up to four, five and seven years.

Actavis licensed the U.S. commercial rights for Levosert, and Medicines360 retained rights to market the product in the U.S. public sector, including family planning clinics that provide services to low-income women.

Liletta is expected to be available for use in the U.S. by Q2 2015.

Want to know which drugs are facing the FDA decision dates in March?

Check http://www.rttnews.com/CorpInfo/FDACalendar.aspx for more information.