The FDA has again extended the indication for Erbitux (cetuximab) and approved the treatment for patients with advanced head and neck cancers in combination with chemotherapy.

The extension is based on the EXTREME study of 442 patients previously untreated with chemotherapy that demonstrated those treated with Erbitux lived 10.1 months on average, compared with 7.4 months on those treated with chemotherapy alone.

Richard Pazdur, Head of Oncology, FDA, says the medication is an “important tool” for doctors and patients.

Erbitux is now approved for five separate indications across two tumour types and becomes the first regimen in 30 years with extended overall survival in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck to be approved.

Eli Lilly and Amylin Pharmaceuticals have mutually terminated their decade-long diabetes partnership for exenatide.

As part of the global agreement, Amylin will gain full responsibility for the drug and make an upfront payment of $250 million, plus 15% of future global net sales to Lilly, up to the combined total of $1.2 billion.

Enrique Conterno, President of Lilly Diabetes, said: “This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together.”

The partnership between Amylin and Lilly provided various innovations to the diabetes market, including Byetta and Bydureon.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA in April 2005. It is an injectable prescription that improves glucose control in adults with type 2 diabetes mellitus, when used in conjunction with a diet and exercise programme.

Investigational Bydureon received marketing authorisation in the EU in June 2011 for type 2 diabetes, and is currently under review in the US.

Daniel M. Bradbury, President and CEO of Amylin, said: “We anticipate working with one or more partners outside the US in order to maximise the global potential of this innovative molecule and achieve greater operational flexibility and efficiency.”

The mutual agreement confirms that Amylin will resume worldwide drug development and commercialisation, starting in the US and progressing to all markets by the end of 2013.

The FDA has approved Cordis Corporation’s Empira and Empira NC RX PTCA dilatation catheters for the treatment of coronary artery disease.

Both balloon catheters are designed to allow cardiologists to open patients’ narrowed coronary arteries during angioplasty procedures.

Dr Campbell Rogers, Chief Scientific Officer and Global Head of R&D at Cordis, said that the company “worked closely with physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the Empira Balloon Catheters will meet physicians' needs and has the potential to improve patient outcomes”.

The two medical devices bring several design and technology alterations to Cordis’ portfolio of Empira balloon catheters. They feature the company’s next generation Duralyn Flex balloon material, which is 50% more flexible than the material used in the current Fire Star and Dura Star RX PTCA dilatation catheters, to improve crossability and recrossability, the ability to pass through a lesion.

Cordis Corporation is a Johnson & Johnson company, and develops and manufactures interventional vascular technology. The company works with interventional cardiologists, radiologists and vascular surgeons to treat patients with vascular disease.

The products are expected to be launched for sale in early 2012.

The FDA has approved Sapien transcatheter heart valve (THV), an artificial aortic heart valve that can be placed without open-heart surgery.

Edward Lifescience’s device is the first artificial copy of an aortic heart valve to replace valves that have been damaged by senile aortic valve stenosis without open-heart surgery.

Dr Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health, said that the artificial valve “is an example of an innovative new device that will provide some people with this condition who can't undergo open heart surgery with the option of valve replacement”.

The approval was based on a study of 365 patients who were not eligible for open-heart surgery, half of which received the Sapien valve, the rest were given an alternative therapy that did not require open-heart surgery.

The study showed that patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant.

However, Sapien patients were more likely to survive one year after surgery, with 69% alive compared with 50% of those who received an alternative treatment.

Patients with severe aortic valve stenosis would usually have to undergo open-heart surgery to replace the valve, but some patients are unable to do so.

According to the FDA, more than half of all patients will die within two years of the onset of senile aortic stenosis.

Senile aortic valve stenosis is a progressive disease that can affect elderly patients. The condition incurs an accumulation of calcium deposits on the aortic valve, causing the valve to become narrower.

The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

The FDA has approved Spinal USA’s two spinal treatment products, the VAULT Stand Alone ALIF System and the S-Lok PC Posterior Cervical System (pictured, right).

Rich Dickerson, Senior Vice President of Operations for Spinal USA, said that the two medical devices “provide our customers with a wider array of surgical options”.

The VAULT System (pictured, below) is designed for use with autogenous bone graft for intervertebral body fusion of the spine in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, aiming to “reduce surgical trauma and yield a net cost saving”, said Mr Dickerson.

He added that the S-Lok PC Posterior Cervical System offers “surgeons a comprehensive fixation system with enhanced ease of use and greater intraoperative flexibility”, indicated to promote fusion of the cervical and thoracic spine in mature patients in the treatment of DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, and revision of previous cervical spine surgery and tumours.

DDD is characterised by back pain caused by the degeneration of the disc. Spondylolithesis is a condition in which a bone in the lower part of the spine slips out of place.

Cervical spine surgery is intended to restore nerve function, stop or prevent abnormal motion in the spine, and relieve pain, numbness, tingling and weakness.

Mississippi-based Spinal USA provides spine products for the treatment of serious medical conditions, aiming to reduce medical costs.

The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).

The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.

Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians.”

The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.

Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.”

“We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.

The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.

BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.

MedX Health’s skin imaging diagnostic systems, MoleMate and SIMSYS, have been granted FDA approval for sale in the US.

These non-invasive medical technologies use light to look beneath suspicious moles, creating accurate images to help physicians evaluate lesions, often eliminating the need for painful and expensive skin biopsies.

Steve Guillen, President and CEO of MedX Health, said: “The US market alone is estimated to be a $1 billion opportunity, and MoleMate and SIMSYS are the only FDA approved and patent protected siascopy products in this important health segment.”

MoleMate features a hand-held scanner designed for office use, providing images of the pigment, blood, and collagen below the mole or lesion.

SIMSYS allows image capture and storage as well as special features that can be used to compare moles. It will support ‘mole mapping’ in 2012, where the entire surface of the patient's skin is photographed to observe changes over time, so that suspicious moles can be monitored more closely.

Dr. R. H. Falcon, a dermatologist in New York, said: “I chose this technology because it gives me extra information about my patients’ suspicious moles and lesions through the additional views of the skin and helps me and the patients to come to a more informed decision about removal.”

Almost 13 million people in the US have a history of non-melanoma skin cancer, usually diagnosed as basal cell carcinoma or squamous cell carcinoma. The survival rate for patients whose melanoma is detected early is about 99%. This statistic falls to 15% for patients with advanced disease.

The MoleMate and SIMSYS medical technologies are already available in Australia, Europe and the UK.

The FDA has approved Remicade to treat moderately to severely active ulcerative colitis (UC) in children older than six years in the US.

Janssen Biotech’s infliximab treatment is indicated to reduce the signs and symptoms of UC in patients whose condition has not responded to conventional therapy, aiming to induce and maintain clinical remission.

The approval was based on findings from a multi-centre, randomised, open-label study involving 60 children aged six to 17 years old with moderately to severely active UC who have failed to respond to or tolerate conventional therapy.

Dr Donna Griebel, Director of the Division of Gastroenterology and Inborn Errors Products at the FDA, said: “With the approval of Remicade, children with moderately to severely active ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option.”

Remicade carries a Boxed Warning for risk of serious infections and cancer. These infections include tuberculosis and those caused by viruses, fungi or bacteria.

The drug is already approved for the treatment of other autoimmune diseases such as Crohn’s disease in adults and children older than six years, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), psoriatic arthritis and plaque psoriasis in adults.

UC is a form of inflammatory bowel disease (IBD) that affects the lining of the large intestine and rectum. Between 50,000 and 100,000 children in the US have IBD, with 40% of this figure having UC.

The FDA has approved a new diagnostic test that will help save hundreds of thousands of lives of AIDS patients with fungal meningitis.

The rapid blood test, CrAg Lateral Flow Assay, requires no equipment, able to diagnose the early presence of cryptococcosis, a leading cause of AIDS-related deaths in developing countries.

The point-of-care dipstick was developed by Tom Kozel, Professor of Microbiology at the University of Nevada School of Medicine, and Sean Bauman, President and CEO of IMMY (Immuno-Mycologics) in Oklahoma. Mr Bauman commercialised the product to make it available at low cost to patients in developing countries.

Sean Bauman, President and CEO of IMMY (Immuno-Mycologics), Oklahoma, and developer of the test, said: “A health-care provider can give the test, observe the results, and administer the first dose of oral medication, all within a few minutes, resulting in a life that has truly been changed for the better.”

Current diagnostic tests for cryptococcosis are not suitable for use at resource-limited locations. The tests require special laboratory equipment and refrigeration for storage.

Mr Kozel commented that early identification and treatment is essential to beat the disease, as late diagnosis means antifungal therapy will likely fail in resource-limited countries.

The United States' Center for Disease Control and Prevention has published a fact sheet and established a ‘call to action’ of equipping half of all AIDS clinics in Africa and Asia with the test by 2015, estimating that 50,000 to 100,000 lives will be saved every year.