European licence for Roche HIV drug Viracept recommended for re-instatement

RocheRoche announced today that the European Medicines Agency's (EMEA) Committee for Human Medicinal Products (CHMP) has recommended that Viracept's marketing authorization is re-instated in Europe following its suspension earlier this summer. The Committee stated that it is satisfied with the actions taken by Roche. The positive recommendation is an important step towards lifting the suspension of the marketing authorization and will now go to the EU Commission for a final decision.

Roche fully intends to re-supply Viracept (nelfinavir) once the suspension is lifted. However, it may take a few months for Viracept to be available again to prescribers and patients.

Viracept's license was suspended in August this year following the discovery that some of the drug batches contained a substance called ethyl mesylate (EMS).

"From the beginning of the recall, Roche acted responsibly, quickly and always in the best interests of patients. In a situation such as this, the most prudent action was to recall the medication" said William M. Burns, CEO of Roche's Pharmaceutical Division "We have worked tirelessly with the health authorities, physicians, health care providers, NGO treatment providers and, of course, patient groups on the recall with the full intention of re-supplying this medication."

The Viracept recall affects those countries where Roche-made Viracept is sold or distributed. This excludes the US, Canada and Japan where Pfizer has the responsibility to make and distribute Viracept.

About Viracept
Viracept (nelfinavir), a protease inhibitor is supplied by Roche outside the US, Canada and Japan. Viracept was first introduced by Roche in 1999.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, visit www.roche.com.

Most Popular Now

Salvat Laboratories announces submission of New Dr…

Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsi...

Pfizer's elranatamab granted FDA Breakthrough Ther…

Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administrati...

New insights on antibody responses to Omicron vari…

Knowing how well vaccination against one SARS-CoV-2 strain (with or without previous infection) counteracts infection with a different strain is a critical research quest...

Ancient viral DNA in human genome guards against i…

Viral DNA in human genomes, embedded there from ancient infections, serve as antivirals that protect human cells against certain present-day viruses, according to new res...

The origin-of-life molecule, a key to cancer resea…

RNA, the molecule that gave rise to life, has been shown to be essential for repairing human genetic material and preventing mutations that might lead to developing cance...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...