Expected FDA New Drugs in the Fourth Quarter of 2014

The most promising US FDA new drugs in the fourth quarter of 2014 are mainly three kinds of hepatitis C compound drugs, namely the compound fixed dose of Sofosbuvir +Ledipasvir developed by Gillette, the compound Daclatasvir + Asunaprevir developed by Bristol-Myers Squibb, and AbbVie. Developed Veruprevir + Ombitasvir +Dasabuvir Compound.

With the launch of Gillette's celebrity Hepatitis C drug Sofosbuvir (trade name Sovaldi) in December 2013 and its outstanding market performance, the promising FDA new drugs in the fourth quarter of 2014 were mainly three kinds of hepatitis C compound drugs. This is the fixed-dose combination Sofosbuvir +Ledipasvir developed by Gillette, the Daclatasvir + Asunaprevir compound developed by Bristol-Myers Squibb, and the Veruprevir + Ombitasvir +Dasabuvir compound developed by AbbVie.

Source: Nature Reviews Drug Discovery, September 19, 2014 Online Premier Publishing

One, Gilead's Sofosbuvir+Ledipasvir

Sofosbuvir (trade name Sovaldi) is a HCV NS5B polymerase inhibitor developed by Gillette. It was approved by the US FDA on December 6, 2013. This is the first HCV NS5B polymerase inhibitor drug approved by the US FDA. It is also considered by the FDA as a breakthrough therapeutic drug. Sofosbuvir is the first drug approved for a total oral hepatitis C treatment. When used in the treatment of HCV type 1 chronic hepatitis C, it eliminates the need for traditional injectable drug interferon. Ledipasvir (formerly known as GS-5885) is a HCV NS5A protease inhibitor developed by Gillette and is currently in phase III clinical trials.

On February 10, 2014, Gillette announced that it has submitted a new drug application for the fixed dose of Sofosbuvir +Ledipasvir (90mg/400mg) to the U.S. FDA, which is being developed for the treatment of HCV type 1 chronic hepatitis C adults. Sofosbuvir +Ledipasvir fixed-dose combination drugs have carried out three phase III studies (code-named ION-1, ION-2, ION-3) and included more than 2,000 patients. If the Sofosbuvir +Ledipasvir fixed-dose compound drug can be successfully marketed in the fourth quarter of 2014, it is expected that the drug's annual sales will reach US$2.5 billion in 2015.

2. Daclatasvir + Asunaprevir by Bristol-Myers Squibb

Daclatasvir (previously known as BMS-790052) is an HCV NS5A protease inhibitor that was approved by the European Drug Administration in August 2014 for the treatment of HCV type 1b hepatitis C patients. Asunaprevir (previously known as BMS-650032) is the HCV NS3 protease inhibitor developed by Bristol-Myers Squibb and was first marketed in Japan in 2014 for the treatment of patients with HCV type 1 hepatitis C. The phase III clinical trial of Daclatasvir + Asunaprevir compound drug (codenamed HALLMARK) included more than 600 patients with HCV1b type, with good clinical results.

Therefore, the Daclatasvir + Asunaprevir combination drug is likely to be approved by the US FDA in the fourth quarter of 2014. Daclatasvir + Asunaprevir + BMS-791325 (HCV NS5B polymerase inhibitor) triple combination therapy for hepatitis C is expected to be available in 2015 or 2016.

Three, AbbVie's Veruprevir + Ombitasvir +Dasabuvir

Veruprevir (formerly known as ABT®450) is an HCV NS4A protease inhibitor developed by AbbVie and is currently in Phase III clinical research; Ombitasvir (formerly ABT®267) is an HCV NS5A protease inhibitor developed by AbbVie and is currently Phase II clinical stage; Dasabuvir (formerly known as ABT?333) is an HCV NS5B polymerase inhibitor developed by AbbVie. At present, AbbVie has applied for new drugs to the United States and the European Union.

If Veruprevir + Ombitasvir + Dasabuvir triple combination drug is successfully marketed in the fourth quarter of 2014, it is expected that the drug's annual sales will reach 250 million U.S. dollars in 2015. Although less than $2.5 billion in drug estimates for fixed-dose compounded drugs Gleder Sofosbuvir +Ledipasvir, there is an additional drug option for patients.