FDA approves cheaper version of top-selling diabetes drug

Merck wins OK for long-delayed surgery revival drug

WASHINGTON, Dec 17, (Agencies): Federal health officials have approved a cheaper version of the world’s top-selling insulin from Sanofi for millions of US patients with diabetes.

The Food and Drug Administration approved a new form of Sanofi’s pen-like injector, Lantus, from drugmakers Eli Lilly and Co and Boehringer Ingelheim.

Those companies received tentative FDA approval for their drug, called Basaglar, in August 2014. But the launch was delayed by a patent dispute with Sanofi. The three drugmakers reached an agreement in September allowing the launch of the new drug.

Insulin is a hormone that is crucial for controlling sugar levels in the blood. People with diabetes either do not produce enough insulin or cannot properly use it.

Lantus is the top product for Sanofi and the third best-selling medicine in the world by revenue. British research firm GlobalData says Lantus had sales of $12.4 billion in 2014.

The FDA said Wednesday it approved Basaglar based on data showing it is safe and effective and works similarly to Lantus. The most common side effects reported in company trials included allergic reactions, injection site reactions, itching, rash and weight gain.

Lilly and Boehringer already sell Basaglar in several European countries. The two companies have not set a US price yet, but it likely will be significantly lower than the price for the original product.

The diabetes market is fiercely competitive, and top rivals recently have been introducing new products across several classes of diabetes pills, as well as easierto-use insulins.

Federal health authorities have approved a new drug that helps patients recover from the numbing effects of certain surgical drugs.

The approval of Bridion marks a victory for Merck & Co Inc, which had been seeking marketing clearance for the injectable medication for years.

Bridion is the first drug that reverses the effects of certain muscle-relaxing drugs given along with anesthesia during surgery.

The FDA first rejected the drug in 2008 due to allergic reactions and bleeding

problems seen in some patients. The agency then repeatedly cancelled and rescheduled meetings to review the drug, most recently in March of this year.

The drug was approved in European Union countries in 2009.

Bridion was first developed by rival Schering-Plough Corp, which Merck

acquired in November 2009 for roughly $41 billion.

Drug developer Advaxis Inc said on Wednesday the US Food and Drug Administration had lifted a clinical hold on three of its experimental cancer therapies,

sending the company’s shares up as much as 38 percent.

The US health regulator had in October put on hold mid-stage trials of the company’s lead therapy, axalimogene filolisbac, after a patient died.

Advaxis had then said the patient died due to progression of cervical cancer and that the drug played no role in the death.

The FDA later placed a clinical hold on all three therapies in the company’s pipeline.

Advaxis said on Wednesday that it would resume studies on the three therapies, which belong to a class of treatments that spur the body’s immunity system against the disease.

The company said it had agreed to implement some risk mitigation measures, including revised study design, patient inclusion criteria and patient surveillance measures, following discussions with the FDA.

Advaxis is testing axalimogene filolisbac in patients with head and neck cancer, cervical cancer and anal cancer.

The company is studying ADXS-PSA in prostate cancer patients in combination with Merck & Co’s blockbuster cancer drug Keytruda, and ADXS-HER2 in patients whose cancer is caused by a kind of mutation.

The company’s shares, which had lost about 19 percent since the first clinical hold in October to Tuesday’s close, were up 27 percent at $10.57. They had touched a high of $11.45 earlier.