ViiV Healthcare announces FDA priority review designation for dolutegravir

GlaxoSmithKlineViiV Healthcare announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to dolutegravir submitted for the treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents. A priority review designation is granted to drugs that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The FDA has assigned dolutegravir a Prescription Drug User Fee Act (PDUFA) target date of 17 August, 2013.

The new drug application (NDA) for dolutegravir was received by the FDA on 17 December 2012, and includes the results of four pivotal phase III clinical trials that treated a total of 2553 patients with HIV/AIDS across the treatment spectrum, from therapy naïve to salvage patients. Dolutegravir is in development and subject to evaluation of the benefits and risks by the regulatory authorities before it can be approved and made available on prescription.

ViiV Healthcare submitted a Marketing Authorisation Application (MAA) for dolutegravir to the European Medicines Agency (EMA) on 17 December, 2012.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.

Most Popular Now

Pfizer and BioNTech complete submission to Europea…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted biva...

Lilly will supply an additional 150,000 doses of b…

Eli Lilly and Company (NYSE: LLY) announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately...

Bayer to sell men's health product Nebido™ to Grün…

Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer's men's health product Nebido™ (testosterone undecanoate), for a purchase price ...

AstraZeneca to acquire TeneoTwo and its clinical-s…

AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluatio...

Demonstration of a potent, universal coronavirus m…

The SARS-CoV-2 that causes COVID-19 has killed 6.3 million people worldwide since 2019, painfully highlighting the vulnerability of humanity to novel coronaviruses. Re...

The fourth COVID-19 vaccine reduces the risk of de…

A new study by Tel Aviv University and Ben Gurion University of the Negev, in collaboration with the Israeli Ministry of Health, has found that the fourth COVID-19 vaccin...

Vaccine protection against COVID-19 short-lived, b…

Since COVID-19 vaccines first became available to protect against infection and severe illness, there has been much uncertainty about how long the protection lasts, and w...

Research shows investigational drug fosters nerve …

Scientists from the University of Birmingham have shown that a brain-penetrating candidate drug currently in development as a cancer therapy can foster regeneration of da...

NIH launches clinical trial of mRNA Nipah virus va…

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched an early-stage clinical trial evaluating an inv...

Anti-inflammatory compound shows potential in trea…

An anti-inflammatory compound may have the potential to treat systemic inflammation and brain injury in patients with severe COVID-19 and significantly reduce their chanc...

Vaccine-induced immune response to omicron wanes s…

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substan...

SARS-CoV-2 hijacks nanotubes between neurons to in…

COVID-19 often leads to neurological symptoms, such as a loss of taste or smell, or cognitive impairments (including memory loss and concentration difficulties), both dur...