News

First FDA approval without trials
Enlarge image

Clinical TrialsUK

First FDA approval without trials

18.12.2012 - GSK’s monoclonal antibody against anthrax is the first to get FDA approval without having been tested for efficacy in humans.

This antibody is a very special one: fast track designation, priority review, orphan drug designation – and the first monoclonal antibody approved under the FDA’s Animal Efficacy Rule: On 14 December, the U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK) raxibacumab injections as a treatment against inhalational anthrax. „In addition to antibiotics, raxibacumab will be a useful treatment to have available should an anthrax bioterrorism event occur,“ said the FDA official Edward Cox. The decision comes as no surprise, as GSK announced that the FDA’s Anti-Infective Drugs Advisory Committee voted 16 to 1 in support of the clinical benefit of raxibacumab – with one abstention on 2 November. The antibody was discovered in a joint venture between Cambridge Antibody Technology and Human Genome Sciences with Cambridge Antibody Technology discovering the antibody to Human Genome Sciences' target. In July 2012 HGS was purchased by GSK.

Inhalational anthrax is a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab neutralizes toxins produced by the bacterium that can cause massive and irreversible tissue injury and death. Raxibacumab has additionally been approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Its efficacy has been shown so far in rabbits and monkeys. „Sixty-four percent of animals in the monkey study and 44 percent of animals in one rabbit study receiving the 40 milligrams per kilogram dose of raxibacumab survived exposure to anthrax, compared with none in the placebo groups,“ said GSK in a press release. Trials in humans are not possible due the nature of the disease: Inhalational anthrax is as rare as it is lethal. However, at least the safety of raxibacumab could be demonstrated in 326 healthy human volunteers.

© eurobiotechnews.eu/ml

http://www.european-biotechnology-news.com/news/news/2012-04/first-approval-without-trials.html

BusinessGermany

19.09.2014 In order to concentrate on the life science business, German industry giant Bayer is splitting off its plastics subgroup as a separate company.

FinanceSwitzerland

18.09.2014 Swiss biopharma Cardiorentis has received a €45m investment from overseas investment firm Healthcare Royalty Partners in order to finance the registration for its heart drug.

PoliticsEU

15.09.2014 Jean Claude Juncker, the European Commission President-elect revealed his new Commissioners last week, whilst announcing a change in the units dealing with medicines, medical devices and health technology.

BiosimilarsGermanyFrance

12.09.2014 The 2011 collaboration of Boehringer Ingelheim and Eli Lilly is bearing fruit. An insulin biosimilar developed through the partnership has now been approved in Europe - the first-ever generic version of this class.

FinancingNetherlands

11.09.2014 Cystic fibrosis specialist Proqr Therapeutics has set the terms for its upcoming IPO at US-American stock exchange NASDAQ.

Clinical TrialsUKSweden

09.09.2014 In the midst of the hustle and bustle of the European Respiratory Society’s International Congress 2014, Astrazeneca quietly announced the disappointing results of its latest benralizumab study.

BusinessDenmark

04.09.2014 After their arthritis product’s Phase IIb failure, Novo Nordisk A/S is pulling out of all research and development activities within inflammatory disorders.

BusinessBelgiumIrelandSwitzerland

02.09.2014 In the face of declining revenue, Belgian biopharmaceutical company Thrombogenics has decided to spin out its cancer research and development activities.

ResearchUKSwitzerlandItaly

29.08.2014 Just a week ago, Glaxosmithkline defused the WHO’s claim that an Ebola vaccine could be ready by 2015. Now, the British company’s own candidate vaccine is to be rushed to human trials with the help of funding from an international consortium.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • WILEX2.69 EUR14.47%
  • BAYER112.70 EUR6.17%
  • CO.DON3.32 EUR5.40%

FLOP

  • SYNGENTA310.90 CHF-1.96%
  • SANTHERA88.05 CHF-1.23%
  • ADDEX3.10 CHF-0.96%

TOP

  • CO.DON3.32 EUR32.8%
  • PAION3.05 EUR27.1%
  • EPIGENOMICS3.83 EUR22.8%

FLOP

  • ADDEX3.10 CHF-22.5%
  • EVOTEC3.08 EUR-16.1%
  • MEDIGENE3.93 EUR-14.6%

TOP

  • SANTHERA88.05 CHF2058.1%
  • CO.DON3.32 EUR277.3%
  • PAION3.05 EUR202.0%

FLOP

  • CYTOS0.24 CHF-94.0%
  • THERAMETRICS0.09 CHF-40.0%
  • BIOFRONTERA2.20 EUR-39.7%

No liability assumed, Date: 18.09.2014