Medical, Health & Drug Prescription News » New Drug Approvals

Gaucher Treatment Drug prGCD Newly Approved

admin — Wed, 19 Aug 2009 18:34:38 +0000

Although, prGCD, a new drug used to treat patients with a unique genetic disorder – Gaucher disease, has not received full market approval, the U.S. FDA has said that physicians may utilize the drug for treatment.

The Associated Press has reported that the FDA has endorsed a treatment procedure that will permit Protalix BioTherapeutics Inc. to provide clinical trial patients with prGCD. This comes as a result of an FDA inspection that has lead to a shortage of Cerezyme, due to the fact they were ordered to abandon most of their ingredients.

According to the AP, under the FDA’s treatment procedure, the clinical trial patients will be treated with prGCD for free until the drug is fully approved.

FDA Endorses Multiple Sclerosis Treatment, Extavia

admin — Mon, 17 Aug 2009 21:22:16 +0000

Novartis has recently announced the U.S. FDA approval of their multiple sclerosis treatment drug: Extavia (Interferon beta 1-b). The FDA approved the drug for patients that suffer from a relapse of the auto immune disease, or for those patients whom are newly diagnosed with MS.

Novartis states that multiple sclerosis effects roughly 400,000 Americans, and of those people nearly 80 percent have the relapsing-remitting class. MS patients’ own bodies attack the protective tissue that surround nerve fibers. These nerves are responsible for transmitting electric signals to the brain. As a result people display such symptoms as the inability to control their muscles, effected vision, balance, sensation and mental functions.

Norvartis claims that Interferon 1-b has been used at treatment for MS for over 16 years, and should be used with caution on people with depression. Adverse reactions among Extavia patients include reactions at the injection site, flu-like symptoms, headache and pain.

Saphris Sublingual Tabs Receives FDA Endorsement

admin — Mon, 17 Aug 2009 20:38:51 +0000

The US FDA has approved Saphris sublingual tablets for the acute therapy of schizophrenic adults, as well as the acute therapy of manic or mixed bipolar I disorder, with or without adult psychotic attributes. Saphris is endorsed for first-line therapy, and is the first prescription drug to receive primary consent for both of these symptoms concurrently.

Shering-Plough, the research company behind Saphris are overly “pleased with the U.S. approval of Saphris, which represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment.” Schering – Plough Research Institute, executive vice president and president Thomas P. Koestler, PhD went on to express their excitement with Saphris’ addition to their “product portfolio, and represents the first U.S. approval resulting from Organon/Schering – Plough combination.”

The FDA endorses Saphris, issues from a New Drug Application that contains efficacy data from their clinical study program which encompassed roughly 3,000 schizophrenic and mania trial patients. Saphris’ new drug application was also reinforced by safety data issued from 4,500 people, some of which were treated for over two years. The FDA’s endorsement stems from acute schizophrenia trials, where Saphris showed noteworthy statistical efficacy when compared with placebo and acute bipolar l disorder studies, in which, Saphris proved statistically, an immense lowering of bipolar symptoms versus that of the placebo trials.

Baxter Completes CELVAPAN A/H1N1 Pandemic Vaccine

admin — Fri, 07 Aug 2009 16:32:44 +0000

Baxter International has recently announced that they have finished the production of their first commerical batches of CELVAPAN A/H1N1 pandemic vaccine. Currently, Baxter is discussing distribution options with national health authorities, so long as they receive appropriate permission. Baxter implemented their proprietary Vero cell production technology when developing CELVAPAN.

When the World Health Organization increased the pandemic notification level to phase 6 and announced it as an official pandemic, many health authorities began to place orders for the vaccine. As a result, Baxter plans to provide their initial CELVAPAN quantities to the health authorities who have created pandemic contracts with them.

Vero cell production technology, has met all Baxter’s expectations. The technology was able to respond to the pandemic, and in return quickly produce a vaccine within 12 weeks of receiving the A/H1N1 virus strain.

Joy Amundson, corporate vice president and president of Baxter BioScience proudly stated “we are pleased with our company’s ability to meet its expected timelines in developing and producing CELVAPAN … [it] is an encouraging validation of our science, our Vero cell vaccine technology and the teamwork at Baxter in meeting this important milestone to help address an urgent public health issue.”

In an effort to abide with all regulatory authorities, requirements, Baxter is working with regulatory authorities to ensure support and approvals of CELVAPAN are achieved. Baxter produced a mock-vaccine which consisted of several pandemic strains and tested it in five worldwide clinical trials consisting of over 1300 people. Plus, over 3,500 people have been vaccinated during their ongoing phase lll study.

US FDA Supports Once-Daily Diabetes Treatment Onglyza

admin — Fri, 07 Aug 2009 16:03:25 +0000

Recently, the US FDA has approved a once-daily tablet to treat adult Type 2 Diabetes. Along with diet and exercise, Onglyza will assist to manage high blood sugar levels.

In people who do not suffer from diabetes, the hormone insulin maintains glucose levels. People who do suffer from diabetes either display immunity to the insulin, or they don’t yield an adequate amount of insulin to retain normal blood glucose levels.

Onglyza belongs to a group of drugs: dipeptidyl peptidase – 4 inhibitors. These treatment options activate insulin secretion from the pancreas post meals.

The FDA’s Center for Drug Evaluation and Research states, “Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes … high blood sugar levels can cause blurry vision and excessive urination … eventually resulting in serious conditions as kidney and eye disease.”

As a result of Onglyza, the most common side effects include upper respiratory tract infection, urinary tract infection, and headache, as well as, rash and hive allergy-like reactions.

The FDA’s validation of Onglyza comes after the results of eight clinical trials.

US FDA Supports Antipsychotic Once-Monthly Invega Sustenna

admin — Fri, 07 Aug 2009 15:57:52 +0000

The US FDA has recently approved Invega Sustenna extended-release injectable suspension for acute and maintenance therapy of adult schizophrenia. Invega Sustenna is the first US approved once a month injectable, long-acting, atypical antipsychotic. The Janssen sector of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will be responsible for the US marketing of Invega Sustenna.

Schizophrenia is a severe brain disorder that effects roughly one percent of the world’s population. The disorder compromises a person’s capacity to think clearly, identify with others, and differentiate between fantasy and reality. Although there is no cure for Schizophrenia, symptoms and risk of relapse can generally be supervised with treatment that includes ongoing, long-term therapy and antipsychotic medications.

Studies show that 80 percent of schizophrenic patients will experience at least one relapse within five years of original diagnosis. Patients who are treated using an oral atypical antipsychotic will fail to take their medication one-third of the year. As a result, it is key for healthcare providers to assure that patients are engaging with their treatment course, to diminish the chance of relapse.

Psychiatry and Neuroscience professor and director at the University of Cincinnati College of Medicine, and a clinical investigators who worked on the Invega Sustenna trials, Henry A. Nasrallah, M.D., states that “Inconsistent compliance with medication is one of the single greatest impediments to managing the symptoms of schizophrenia and delaying relapse … the approval of once-monthly Invega Sustenna will provide healthcare professionals with a treatment option that is … a monitoring tool for uninterrupted medication compliance, which may help optimize clinical outcomes in schizophrenia.

The FDA endorsement is a result of four acute symptom control studies and a longer-term maintenance study that compared placebo to Invega Sustenna. Invega Sustenna surpassed the placebo by progressing positive and negative syndrome scale total scores, and in the longer-term maintenance study delayed time to relapse.

During clinical trials, frequent side-effects included reactions at the site of injection, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.

2009 – 2010 Seasonal Influenza Vaccine approved by FDA

admin — Thu, 06 Aug 2009 20:39:15 +0000

The US FDA has reported seasonal influenza vaccine approval for 2009 and 2010.

Although the vaccine does not protect citizens against the H1N1 influenza vaccine (the recent influenza that has been publicized by the World Health Organization as a pandemic), the FDA continues to work with manufacturers , government officials and international relations to advance the availability of a safe and accessible vaccine to fight the H1N1 influenza virus.

Margaret A. Hamburg, commissioner of Food and Drugs supports “the approval of this year’s influenza vaccine [as] an example of the FDA’s important responsibility to assure timely availability of [the] vaccine to help protect the health of the American public.”

The six brand names and manufacturers that will be representing the vaccine are: Afluria, CSL Limited; Fluraix, GlaxoSmithKline Biologicals; FluLaval. ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Ltd.; Fluzone, Sanofi pasteur Inc.; and FluMist, Medimmune Vaccines Inc.

The CDC estimates that 5 – 20% of the US population succumbs to influenza each year. More than 200,000 people become hospitalized due to its effects, and roughly 36,000 lose their lives to the virus.

Onsolis Slated to be Marketed After FDA Approval

admin — Thu, 06 Aug 2009 20:18:13 +0000

The US FDA has officially announced their approval to market Onsolis, an advanced treatment used for the management of breakthrough pain, for cancer patients over the age of eighteen, who already receive and have built a tolerance to opiod therapy for unrelenting cancer pain.

Onsolis is the first product on the market to use the company’s BEMA technology (BioErodible MucoAdhesive). This drug delivery technology is composed of a small dissolvable polymer film which is applied to the patient’s inner lining of the cheek.

Onsolis is set to be made available in the fourth quarter of 2009, and will later be commercialized in the US by Meda Pharmaceuticals

FDA Signs Off on Plan B One-Step Emergency Contraceptive

admin — Thu, 06 Aug 2009 19:54:06 +0000

Women may relish in the peace of mind that the One-Step contraceptive, an available option should the fear of an unwanted pregnancy arise. The FDA has expanded over-the-counter access to Plan B to include women 17 years and older (with government issued ID), and those under the age of 17 must present the pharmacist a prescription.

Amy Niemann, General Manager and Senior VP of Teva Women’s Health, expresses pride as she states: “We’re proud to offer women this new, innovative emergency contraceptive option that builds upon the trust that women have come to know with Plan B.”

Taken within 72 hours of unprotected sex or contraception failure, Plan B One-Step dramatically increases the chances of reducing the likelihood of pregnancy. Studies prove that seven out of eight women who would have gotten pregnant did not after taking the oral contraceptive. The sooner the woman takes Plan B One-Step the better her chances of avoiding an unwanted pregnancy. Although One-Step reduces the risks of pregnancy, the emergency contraceptive does not terminate an existing pregnancy.