News

Avastin less safe than Lucentis as AMD therapy
Enlarge image

BusinessSwitzerland

Avastin less safe than Lucentis as AMD therapy

02.05.2012 - Results from a NIH study confirm that treating wet AMD with unlicensed Avastin (bevacizumab) leads to more adverse effects than Novartis’ Lucentis.

Basel - Novartis AG has highlighted results from a head-to-head study comparing safety and efficacy of the VEGF antibody fragment Lucentis (ranibizumab) with the full VEGF antibody Avastin (bevazizumab) in wet AMD therapy. According to the NIH-funded CATT study (Comparison of Age-related macular degeneration Treatment Trials), Lucentis showed superior safety when compared to Avastin, which has been not approved as treatment for wet AMD but has been broadly used off label by ophtalmologists due primarily to a 50fold lower price.

According to Novartis, which has licensed marketing rights from Roche for Lucentis, two year data from 1107 patients confirm 30% higher risk of serious systemic adverse events with unlicensed bevacizumab versus Lucentis. Additionally, the Swiss pharma major pointed to reports of arteriothrombotic events, systemic haemorrhage, congestive heart failure, venous thrombotic events, hypertension and vascular death, which were more frequent in bevacizumab treated patients. These events have been previously associated with systemic anti-VEGF treatment.

"The apparent differential safety risk between the two medicines may be due to differences in the molecules and their commercial formulation“, said Tim Wright, Global Head of Development, Novartis Pharma. Previously published retrospective Medicare analyses compared the safety of unlicensed ocular bevacizumab and Lucentis for treating wet AMD. The primary analysis from the Curtis study showed that unlicensed bevacizumab and Lucentis were not associated with increased risks of death, heart attack, bleeding or stroke compared with photodynamic therapy or pegaptanib. A secondary analysis in the Curtis et al study, which included approximately 40,000 patients, showed a significantly higher risk of mortality (16%) and stroke (28%) with unlicensed intravitreal bevacizumab than with Lucentis. Gower et al. assessed 77,886 Medicare beneficiaries with wet AMD over 10 months. In this study patients treated with unlicensed intravitreal bevacizumab experienced an 11% significantly increased risk of death and a 57% significantly increased risk of haemorrhagic stroke compared to patients treated with Lucentis. The risk of ocular inflammation was 80% higher with unlicensed intravitreal bevacizumab than with Lucentis.

http://www.european-biotechnology-news.com/news/news/2012-02/avastin-less-safe-than-lucentis-as-amd-therapy.html

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.

BusinessGermany

24.08.2014 Germany's Morphosys is licensing a preclinical bi-specific antibody for the treatment of prostate cancer from Emergent Biosolutions. The US developer will rake in up to €138m for the commercialisation rights to the compound.

BusinessUK

20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • CO.DON2.84 EUR4.80%
  • VITA 343.98 EUR4.19%
  • MEDIGENE4.07 EUR2.26%

FLOP

  • THERAMETRICS0.08 CHF-11.11%
  • CYTOS0.24 CHF-4.00%
  • BASILEA97.25 CHF-1.22%

TOP

  • SANTHERA93.80 CHF46.3%
  • CO.DON2.84 EUR19.3%
  • FORMYCON8.22 EUR18.8%

FLOP

  • EVOTEC3.09 EUR-17.6%
  • MEDIGENE4.07 EUR-13.8%
  • 4SC1.16 EUR-12.8%

TOP

  • SANTHERA93.80 CHF2036.7%
  • CO.DON2.84 EUR226.4%
  • PAION2.69 EUR158.7%

FLOP

  • CYTOS0.24 CHF-94.0%
  • THERAMETRICS0.08 CHF-46.7%
  • MERCK KGAA67.56 EUR-41.3%

No liability assumed, Date: 15.09.2014