China's drug regulator approved Bristol-Myers Squibb Co.'s all-oral treatment for hepatitis C, which will be the first therapy of its kind for the liver disease to be sold in the country, giving the U.S. company a leg up in the Chinese market.
Friday's decision by the China Food and Drug Administration means the estimated 10 million Chinese infected with hepatitis C will be able to gain access to a treatment that has been available in other markets, including Japan, for several years. Chinese patients have mainly relied on older treatments for hepatitis C, which typically involve painful injections of drugs that often produce severe side effects such as headaches and hair loss.
Bristol-Myers's treatment combines two antiviral drugs, daclatasvir and asunaprevir. In its decision, the agency said the combination was approved for treating a type of hepatitis C known as genotype 1b, the most prevalent in China. The regulator also approved daclatasvir for use in combination with other drugs to treat more types of the disease.
Left untreated, hepatitis C can scar the liver, lead to liver cancer and even result in death. More people in China are infected than the rest of the world combined, according to Bristol. But until the approval of the company's drug, China didn't authorize use of one of the direct-acting all-pill regimens that have transformed treatment in the U.S., Europe and other countries, curing nearly all patients with a few year's treatment and without painful injections.
Murdo Gordon, Bristol's chief commercial officer, said it may take a few months to work out distribution and reimbursement details before patients can start getting the drug. "There are a few steps still to take, but the significance of this is huge," he said. "We have an opportunity to cure upwards of 90%" of patients.
The dual regimen was first approved for use in Japan in 2014. It wasn't marketed in the U.S., however, because Bristol-Myers later that year withdrew its FDA application for asunaprevir as competing drugs were nearing approval. Daclatasvir was approved by the FDA for use in a combined therapy with U.S.-based Gilead Sciences Inc.'s blockbuster drug Sovaldi to treat hepatitis C.
China's drug regulator is trying to accelerate its review process for innovative medicines with huge clinical demand. In the past few months, a number of imported drugs have been approved for the Chinese market, including AstraZeneca PLC's lung cancer drug Tagrisso and Novartis AG's Votrient for kidney cancer.
Mr. Gordon said daclatasvir's approval provides "clear evidence" that the efforts multinational pharmaceutical companies have undertaken to realize the potential of China's vast market are starting to pan out. "The government can work in partnership in a very effective manner" when it views a disease as a major public-health threat, he said.
Approval for Bristol-Myers's hepatitis C treatment likely presages fierce competition with other drugmakers for a share of the Chinese market. Gilead, Johnson & Johnson unit Janssen Pharmaceuticals Inc. and domestic startup Ascletis Pharmaceuticals have products that are nearing approval, according to drug administration records.
New York-based Bristol-Myers hasn't disclosed pricing for the newly approved drugs, but a company representative said Friday it would depend on how quickly the drugs gain approval for inclusion in reimbursement programs at the national and provincial levels. The wholesale acquisition cost -- the price paid by hospitals and other large purchasers -- for a 12-week course of treatment for daclatasvir is $63,000, according to hepatitis C Online, a site maintained by the University of Washington. A combined regimen would cost more.
A high price tag is likely to be prohibitive in China. The country's regulators are giving foreign drugmakers greater access to the domestic market in hopes that competition will help bring prices down. Hepatitis C is more common in rural areas and small cities where incomes are typically lower. Some Chinese patients have traveled overseas to obtain less expensive versions of treatments for the disease.
(END) Dow Jones Newswires
April 28, 2017 11:58 ET (15:58 GMT)