Please login to the form below

Not currently logged in
Email:
Password:

FDA grants orphan status to Activartis’ brain cancer immunotherapy

Regulator says AV0113 has potential in rare cancer malignant glioma

Activartis

Activartis received a boost this week when the US Food and Drug Administration (FDA) granted orphan drug status to its investigational cancer immunotherapy AV0113.

The Austria-based biotech said the US regulator gave the designation for AV0113's use in the treatment malignant glioma, a rare and very aggressive type of brain cancer.

This adds to the existing orphan drug designation for AV0113 granted by the European Medicines Agency (EMA).

The two regulatory bodies reserve orphan status for drugs to treat diseases that affect only a limited proportion of the population.

This designation is intended to support research efforts in these less lucrative markets, and provide companies with motivations, such as tax credits and marketing incentives.

These incentives appear to be working, with the EMA reporting last year that orphan drug applications were up 30 per cent for the first six months of 2012.

A Thomson Reuters' report also described orphan drugs as an economically viable market for pharma.

Activartis' AV0113 is part of this growing trend, and the drug has shown promise in early-stage trials.

The company has now completed recruitment of 78 brain cancer patients to a multi-centre, randomised, phase II clinical trial, which aims to deliver safety and efficacy data for the first time.

According to Activartis, preliminary results revealed a “very promising trend” towards overall survival benefit in patients taking AV0113.

The drug acts as an immunotherapy, activating the patient's immune system to fight tumour cells.

It does this by convincing the body's dendritic cells that there are dangerous molecules, causing these cells to go into a pro-inflammatory mode of action.

This activates tumour-specific T-cells, which are able to recognise and destroy tumour cells.

Other companies banking on immunotherapies in the fight against cancer include Merck Serono, which last month set up a dedicated R&D unit for such therapies.

Cancer immunotherapies already on the market include Bristol-Myers Squibb's Yervoy (ipilimumab) for melanoma, which posted sales of $706m in 2012, its first full-year on the market after debuting in the US in March 2011.

4th July 2013

From: Research, Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
dna Medical Communications

dna: as different as you. Every patient, disease and therapy is di­fferent. As is every message, stakeholder and educational challenge....

Latest intelligence

Growing influence of pharmacists in the sale of Rx and OTC medicines
Find out how the changes within pharmacy have affected their influence over the sales of RX and OTC medicines in this whitepaper....
Drivers of 2014′s Soaring Drug Approvals
The FDA & EMA approved a chart-topping number of new drugs in 2014. Read more in our White Paper about the responsibility this growing approval success will put on future...
Russian innovation at the crossroads
Despite improvements, investors face rising risks...