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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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India Developing $1 Vaccine for a diarrhea-causing virus that is one of the leading causes of childhood deaths across the developing world.
INDIA |
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14 may 2013
The Indian government announced the development of a new low-cost vaccine proven effective against a diarrhea-causing virus that is one of the leading causes of childhood deaths across the developing world.
The Indian manufacturer of the new rotavirus vaccine pledged to sell it for $1 a dose, a significant discount from the cost of the current vaccines on the market. That reduced price would make it far easier for poor countries to vaccinate their children against the deadly virus, health experts said.
Rotavirus, spread through contaminated hands and surfaces, kills about half a million children across the world each year, 100,000 of them in India.
At a conference Tuesday, the government announced that Phase 3 trials of Rotavac proved that it was safe as well as effective. The clinical trial of 6,799 infants at three sites in India showed the vaccine reduced severe cases of diarrhea caused by rotavirus by 56% during the first year of life.
“The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India,” said Dr. K. Vijay Raghavan, the secretary of the Department of Biotechnology.
The vaccine still needs to be licensed before it can be distributed in India and would require further approval by the World Health Organization before it could be distributed globally.
Two other vaccines have proven effective against rotavirus, but they are significantly more expensive.
The GAVI Alliance, which works to deliver vaccines to the world’s poor, negotiated a significant discount last year with GlaxoSmithKline and Merck, obtaining the rotavirus vaccines from those pharmaceutical companies for $2.50 a dose. The alliance has programs for delivering those vaccines in 14 countries and plans to expand them to 30 countries.
Dr. Seth Berkley, the GAVI Alliance’s CEO, said the announcement was “a big deal.”
“The cheaper the price the more children you can immunize,” he said, adding that it will still take some time before the vaccine is approved for use.
In addition, having a third manufacturer for the vaccines would ease supply shortages and could drive down the costs charged by the other manufacturers, he said.
“That would make a big difference in terms of changing the marketplace,” he said.
Diarrhea is the second leading cause of death among young children in the world after pneumonia. A study of 22,568 children at sites in seven African and south Asian countries that was published in the medical journal The Lancet showed that rotavirus was the leading cause of moderate to severe diarrhea in children under the age of two.
The new vaccine was developed from a weakened strain of the virus taken from a child hospitalized in New Delhi more than a quarter century ago. It was the result of a broad global partnership that included the government, the Indian company Bharat Biotech, the Bill and Melinda Gates Foundation and the U.S. Centers for Disease Control and Prevention, among many others.
Those involved said the broad cooperation reduced research costs for the manufacturer and helped keep the vaccine inexpensive.
“This public-private partnership is an exemplary model of how to develop affordable technologies to save lives,” Bill Gates, co-chair of the Gates Foundation, said in a statement.
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
May 15, 2013 — The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.
Ulcerative colitis is a chronic disease that affects about 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, production of pus and diarrhea.
“Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis,” said Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently.”
The safety and effectiveness of Simponi for ulcerative colitis were established in two clinical studies. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician’s overall assessment.
In the first study, 513 patients with moderate to severe ulcerative colitis who could not tolerate or failed to respond to other therapies were randomly assigned to receive Simponi or a placebo. Results showed that a greater proportion of Simponi-treated patients achieved clinical response, clinical remission and, as seen during endoscopy, had improved appearance of the colon after six weeks compared with the placebo group.
In the second study, 310 patients with moderate to severe ulcerative colitis who were responders to Simponi were randomly assigned to receive Simponi or placebo. A greater proportion of Simponi-treated patients maintained clinical response through week 54, had clinical remission at both weeks 30 and 54 and, as seen during endoscopy, had improved appearance of the colon at both weeks 30 and 54 compared with the placebo group.
The most common side effects in patients treated with Simponi are upper respiratory infection and redness at the site of injection. Patients treated with Simponi are at increased risk of developing serious infections, invasive fungal infections, reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders and allergic reactions.
Simponi is marketed by Horsham, Penn.-based Janssen Ortho Biotech, Inc
Golimumab (CNTO 148) is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor.
Golimumab was developed by Centocor and is approved in Canada and the United States as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.Golimumab is pending FDA approval for Ulcerative Colitis.
In the same year, Johnson & Johnson, the parent company of Centocor, also received an approval from European Medicines Agency (EMEA) for the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab is marketed by Merck & Co, Inc. in Europe, pending final arbitration between J&J and Merck.
The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs
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FDA Approves Xofigo for Advanced Prostate Cancer
May 15, 2013 — The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.
Xofigo is being approved more than three months ahead of the product’s prescription drug user fee goal date of Aug. 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer.”
In August 2012, the FDA approved Xtandi to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients who have previously been treated the chemotherapy drug docetaxel.
Xofigo’s safety and effectiveness were evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Patients were randomly assigned to receive Xofigo or a placebo plus best standard of care.
The study was designed to measure overall survival. Results from a pre-planned interim analysis showed men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo. An exploratory updated analysis conducted later in the trial confirmed Xofigo’s ability to extend overall survival.
The most common side effects reported during clinical trials in men receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).
Xofigo is marketed by Wayne, N.J.-based Bayer Pharmaceuticals. Xtandi is co-marketed by Astellas Pharma U.S., Inc. of Northbrook, Ill., and Medivation, Inc. of San Francisco, Calif.
Potenntial diabetes breakthrough Harvard researchers discover hormone that spurs beta cell production; research boosted by federal funding
Researchers at the Harvard Stem Cell Institute (HSCI) have discovered a hormone that holds promise for a dramatically more effective treatment of type 2 diabetes, a metabolic illness afflicting an estimated 26 million Americans. The researchers believe that the hormone might also have a role in treating type 1, or juvenile, diabetes.
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Beer’s Bitter Compounds Could Help Brew New Medicines
Seattle, WA (Scicasts) – Researchers employing a century-old observational technique have determined the precise configuration of humulones, substances derived from hops that give beer its distinctive flavour. That might not sound like a big deal to the average brewmaster, but the findings overturn results reported in scientific literature in the last 40 years and could lead to new pharmaceuticals to treat diabetes, some types of cancer and other maladies.
Scientists Develop ‘Magic Bullet’ Nanomedicine for Acute Lung Injury
Northern Ireland, UK (Scicasts) – Researchers at Queen’s University Belfast have devised a ‘magic bullet’ nanomedicine which could become the first effective treatment for Acute Lung Injury or ALI, a condition affecting 20 per cent of all patients in intensive care.
Janssen gets speedy review for Hep C drug
simeprevir
US regulators have agreed to conduct an accelerated review of Janssen Research & Development’s investigational hepatitis C drug simeprevir.
The product, which is under review as a combination treatment for genotype 1 hepatitis C in adult patients with compensated liver disease, is an investigational NS3/4A protease inhibitor administered as a 150mg capsule once daily alongside pegylated interferon and ribavirin.
The US Food and Drug Administration grants Priority Review to medicines that potentially offer major advances where no adequate therapies exists, and aims to complete its assessment within six months. As such, Janssen said it expects a decision by November this year.
Simeprevir is also currently being assessed by regulators in Europe and Japan.
Simeprevir (formerly TMC435) is an experimental drug candidate for the treatment of hepatitis C. It is being developed by Medivir and Johnson & Johnson’s pharmaceutical division Janssen Pharmaceutica and is currently in Phase III clinical trials.
Simeprevir is a hepatitis C virus protease inhibitor.
Simeprevir is being tested in combination regimens with pegylated interferon alfa-2a and ribavirin, and in interferon-free regimens with other direct-acting antiviral agents including daclatasvir and sofosbuvir
India shows U.S. path to patent standards, By Swaminathan S. Anklesaria Aiyar MAY 6, 2013
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New Drug Approvals 