Archive for the ‘Therapeutic Classification’ Category

Edoxaban Is FDA Approved As Anticoagulant Therapy

Friday, March 20th, 2015

Edoxaban FDA Approved As Anticoagulant TherapyAs an effectual oral factor Xa inhibitor, Edoxaban is FDA approved as a novel anticoagulant therapy in the U.S. as an anticoagulant in several capacities:

  • To reduce the risk with of both systemic embolism and stroke in patients afflicted with atrial fibrillation (AF), which is not related to heart valve problems.
  • As a treatment for patients with pulmonary embolism and/or deep vein thrombosis (DVT) who have previously had at least 5-10 days of oral parenteral anticoagulant therapy.

While Edoxaban has been examined as a potential treatment for patients with mechanical heart valves and moderate-to-severe mitral stenosis this drug has not received an FDA approval for this use. Effective anti-clotting drugs, like Edoxaban, help to lower the risk of stroke in patients by helping to prevent blood clots from forming in the heart. The need for a wide variety of anticoagulant therapy is great, as many patients find current anti-clotting treatments elicit negative side effects, impacting their medication adherence. While there is a small risk for bleeding and anemia the majority of patients treated with Edoxaban fared well in studies.

Edoxaban, is also known as the brand name Savaysa, which is marketed by Daiichi Sankyo. Clinical trials of Edoxaban (Savaysa) were encouraging. One study involved 21,105 patients suffering from AF, which was not caused by cardiac valve disease. The higher dose of Edoxaban proved to be comparable to Warfarin for reducing stroke risk in patients, with significant decreases in major bleeding events as well. Another trial of patients afflicted with DVT and pulmonary embolism also supported the use of Edoxaban over Warfarin. This trial involved 8,292 participants and sought to reduce the rate of occurrence of symptomatic venous thromboembolism events, including mortality. Approximately 3.2 percent of patients administered Edoxaban experienced symptomatic venous thromboembolism events, as compared to 3.5 percent of the patients who received Warfarin.

LGM Pharma can assist clients as a supplier/distributor of the API Edoxaban CAS# 480449-70-5 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Positive Opinion from the EU for Bevacizumab as Cervical Cancer Treatment

Thursday, March 19th, 2015

BevacizumabKnown as the blockbuster brand name anticancer therapy Avastin, Bevacizumab recently captured a positive opinion from the EU for its success in treating cervical cancer. On March 2, 2015 Roche Pharmaceuticals announced that the European Union’s (EU) Committee for Medicinal Products for Human Use expressed a positive opinion of Bevacizumab when used alongside standard chemotherapy for the treatment of cervical cancer. Studies of Bevacizumab, used in combination with either Paclitaxel and Cisplatin or Paclitaxel and Topotecan, in patients who were unable to receive platinum therapy, proved to be effectual for treating adult females with metastatic carcinoma of the cervix. With an estimated 33,000 new cases of cervical cancer predicted to be diagnosed in the EU in 2015, as well as one third of these patients not surviving this virulent disease, an anticipated approval of Bevacizumab as a therapy for cervical cancer is hopeful. The FDA already approved Bevacizumab in the United States for the treatment of recurrent and metastatic cervical cancer in August 2014. Bevacizumab is currently approved in the EU to treat advanced stages of breast cancer, non-small cell lung cancer, colorectal cancer, ovarian cancer and kidney cancer. The U.S. has approved the additional indications of cervical cancer and progressive glioblastoma following prior therapy for Bevacizumab.

As an effective anticancer medication that interferes with both the spread and growth of cancer cells Bevacizumab is typically given as part of a combination of treatments for cancer patients. Bevacizumab is dispensed intravenously about once every two weeks. While adverse effects can occur from Bevacizumab, such as excess bleeding and difficulty with wound healing, many patients experience tolerable side effects. Reported negative effects from Bevacizumab include body aches, bleeding gums, diarrhea, dizziness and tingling in the limbs.

Studies leading to the FDA approval of Bevacizumab in 2014 and the positive opinion from the EU in March of 2015 offered encouraging data for treating patients with cervical cancer. Initial survey results from studies with Bevacizumab were presented in 2013 at the American Society of Clinical Oncology annual meeting, which showed that patients with metastatic cervical cancer who were administered Bevacizumab lived an average of 3.7 months longer than their counterparts who did not receive this formidable drug. The aforementioned clinical trial, coined GOG240, was sponsored by the National Cancer Institute. The median age of patients was 47 years old and the approximate dose of Bevacizumab was 15 milligrams per kilogram (mg/kg) of their body weight via an intravenous drip. Treatment continued for patients one day every three weeks and was dispensed along with other chemotherapeutic drugs. Progression-free survival was 8.2 months for those patients who were given Bevacizumab, as compared to 5.9 months of progression –free survival for patients who were not administered Bevacizumab. By blocking the blood supply that feeds the tumors Bevacizumab is efficacious for both binding and inhibiting vascular endothelial growth factor. LGM Pharma can assist clients as a supplier/distributor of the API Bevacizumab CAS# 216974-75-3 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Alemtuzumab is a Formidable Therapy for Cancer and Multiple Sclerosis

Wednesday, March 18th, 2015

alemtuzumabKnown as the brand name Campath, which is marketed by Genzyme, Alemtuzumab is a proven therapy for leukemias, lymphomas and recently, multiple sclerosis. As a monoclonal antibody Alemtuzumab effectively binds to the CD52 protein which occurs on cancerous B and T cell lymphocytes. After attaching to the protein on the cells Alemtuzumab elicits other immune cells to help destroy the cancer cells. An intravenous infusion, administered over roughly two hours is how Alemtuzumab is dispensed. Some patients experience much longer infusion periods, such as five or six hours, particularly if it is their first treatment with Alemtuzumab. Dosing is dependent on weight and condition, with most patients receiving daily infusions in a titrated fashion. After a standard best in care dose is reached many patients are administered infusions of Alemtuzumab three times a week for roughly twelve weeks. Adverse effects may occur, and include reports of low platelet counts, fever, nausea and vomiting. The FDA approved Alemtuzumab in 2001 for the treatment of chronic leukemias and lymphoma.

A new FDA approval for Alemtuzumab was announced in November 2014, with a nod given to Genzyme’s Lemtrada, for the treatment of multiple sclerosis (MS). Indicated specifically for patients with relapsing forms of MS, Lemtrada (Alemtuzumab) is reserved for patients who have had inadequate responses to at least two current therapies for MS. Two successful trials of Alemtuzumab, which compared Lemtrada to Rebif in patients with relapsing MS, showed Alemtuzumab was more effective. This duo of randomized trials involved just about 1,500 patients with refractory multiple sclerosis and included over 6,400 patient-years of follow-up safety studies. While Alemtuzumab does include a boxed warning as the MS drug Lemtrada, the risk of fatal autoimmune conditions is uncommon. However, as of now Lemtrada is only available via a restricted distribution program in the United States. The dosing schedule of Alemtuzumab as Lemtrada for patients with remitting MS is unique, with two treatments dispensed annually. The first administration is given for five consecutive days through an intravenous infusion. The second dosage does not occur until roughly twelve months later, and is dispensed for three consecutive days. Side effects noted from study participants who received Lemtrada included nausea, dizziness, rash, fatigue and flushing. Lemtrada (Alemtuzumab) was approved in the EU in September of 2013 to treat multiple sclerosis.

The potential for Alemtuzumab for treating a wide swath of life threatening illnesses is great. The latest indication for this formidable drug will be a viable option for the 2.3 million people suffering from multiple sclerosis around the globe. In the United States there are approximately 400,000 people who have been diagnosed with MS. LGM Pharma can assist clients as a supplier/distributor of the Alemtuzumab API, CAS # 216503-57-0 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Tadalafil Tested as Possible Dementia Therapy

Monday, March 16th, 2015

tadalafilThe close of 2014 brought exciting news for patients suffering from dementia with the announcement that Tadalafil, a commonly used drug that treats erectile dysfunction, is being tested as a treatment for dementia. The Alzheimer’s Drug Discovery Foundation and the Alzheimer’s Society UK shared the news of their partnership and funding, which would be earmarked for studying Tadalafil as a potential treatment to combat vascular dementia. This is the first study to be done using an erectile dysfunction (ED) drug as a possible therapy for dementia, and plans are underway to create a cross-Atlantic project. One goal set at the G8 summit on dementia was to ascertain a disease-modifying treatment for this devastating disease by 2025, which is now a decade away. Scientists from St. George’s University of London will be spearheading this research, going on the premise that the ability of Tadalafil to increase blood flow will translate to greater blood flow to the brain, thus combating vascular dementia. The study will begin by recruiting 50 patients, all over age 65 who have displayed blood vessel damage, also known as small vessel disease. The patients will also need be documented as experiencing at least mild memory loss. The research will be measured by testing the blood flow to the brain via an arterial spin labelling MRI. Both a Tadalafil and placebo group are planned for this novel study.

ASLAs the second most common form of dementia in America, a diagnosis of vascular dementia is most often caused by brain damage to small blood vessels, leading to a reduction in blood flow to brain tissue. Affecting over one million adults in the United States vascular dementia is diagnosed most often in elderly people. A diagnosis of mixed dementia usually includes vascular dementia, and is found in up to 70 percent of elderly people over age 80. With drug research taking one to several decades to complete, the commencement of this study is exciting as a real possibility for the growing aging population. In the United Kingdom vascular dementia is considered to be the most common form of dementia, accounting for 110,000 cases yearly.

As a carboline-based compound with vasodilatory activity, Tadalafil is an effective inhibitor of the cyclic guanosine monophosphate, resulting in vasodilation, as well as muscle relaxation. The successful of Tadalafil, known as the brand name drug Cialis, has been documented for patients around the world suffering from erectile dysfunction.

LGM Pharma can assist clients as a supplier/distributor of the TEVA API Tadalafil, CAS # 171596-29-5 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

Rizatriptan Gets FDA Nod as New Generic for Migraine Therapy

Thursday, March 12th, 2015

Rizatriptan Gets FDA Nod as New Generic for Migraine TherapyOn January 5, 2015 Jubilant Life Sciences received an FDA nod for their Rizatriptan generic formulation, paving the way for more generic forms of Merck’s blockbuster migraine medication Maxalt. The strengths approved for generic production are both 5 milligrams and 10 milligrams, which makes up an estimated 70 million dollar market. Rizatriptan is an efficacious treatment for patients suffering from migraines, as well as adverse effects which stem from migraines including sensitivity to light and sound, nausea and vomiting. Belonging to a class of drugs known as triptans, Rizatriptan works by affecting serotonin, which causes a narrowing of the blood vessels in the brain. While Rizatriptan does not prevent future migraines it does rapidly alleviate symptoms of a migraine headache, enabling patients to get back to their normal routine as soon as possible.

Rizatriptan is usually prescribed to be taken at the onset of a migraine. Taking Rizatriptan on an empty stomach helps it to work more quickly. Both children and adults can safely be prescribed Rizatriptan, with children being advised not to exceed 5 milligrams daily. Adults should take no more than 30 milligrams in a 24 hour period. Adverse effects from this drug are uncommon. Some patients have reported mild side effects, including dry mouth, dizziness and a tired feeling. An updated report titled “The Prevalence and Burden of Migraine and Severe Headache in the United States: Updated Statistics from Government Health Surveillance Studies” reveals that approximately 14.2 percent of American adults ages 18 and older report experiencing either a migraine or a severe headache in 2012. The prevalence of migraine headaches was highest in females between ages 18 and 44. Migraine headaches are often reported from females who are in their reproductive years, which often coincide with reproductive issues.

MigraineHeadache was documented as the fourth leading cause for patient visits to the emergency room in 2009-2010, with triptans being dispensed in almost 2 percent of patients as treatment. As a whole figures have remained consistent for the major part of the last decade, with migraine headaches affecting 1 out of every 7 Americans annually. Continued research and development of FDA approved generic Rizatriptan is on the forefront of pharmaceutical studies. LGM Pharma can assist clients as a supplier/distributor of the API Rizatriptan, CAS # 145202-66-0 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.