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GLG News by this Author

New twist in ABCD algorithm

September 21, 2009

Analysis of:Novartis gets FDA approval for combo pill valturna to treat high BP | councils.glgroup.com

The FDA have approved a combination of Aliskiren and Valsartan in a fixed dose preparation for the treatment of hypertension. Although initial safety data show efficacy and tolerability in an 8-week study, outcome data on real-life use and in "non-standard" cases of hypertension or other disorders suggests caution be the watchword. Where the 'R' fits into the 'ABCD' algorithm is unclear, as the B is already on the way out and it also lowers renin.

Molecure for rare diseases?

August 18, 2009

Analysis of:FDA Approves Investigational New Drug Application For Prodarsan® In Cockayne Syndrome Patients | www.pipelinereview.com

Cockayne syndrome is a devastating condition that although extremely rare has multisystem effects and a fascinating molecular pathology involving mutations of genes regulating DNA repair. The disease is too uncommon and difficult to diagnose making pre-natal diagnosis and gene therapy unlikely to be practical in the near future.  Targeted molecular therapy modifying the consequence of the defect in DNA repair may be of great significance in a number of fields from oncology to ageing.

Final Piece of the Jigsaw for Takeda and Pioglitazone

July 29, 2009

Analysis of:Takeda Submits a New Drug Application for a Fixed-Dose Combination Tablet of Actos ® with sulfonylurea in Japan | www.pipelinereview.com

Final piece of the jigsaw or flogging the dead horse? The idea of a SU/PIO combination is not new, novel or indeed necessarily the best option for the treatment of type 2 diabetes. It does work, but the potential for weight gain and hypoglycaemia reported in previous real life studies  where SU and TZD were co-administered makes it a potentially high risk combination for use in primary care. The SE-Asia market is growing, but this agent does not add a great deal to what is already out there.

Novartis Targets Global Renin Angiotensin System Inhibition

July 12, 2009

Analysis of:High blood pressure medicine Rasilez gets approval in Japan | www.pharmabiz.com

It has taken a long, long time form oral renin inhibition to come along, and Novartis is seeking to target glomeruli on 5 continents. The South East Asian market is potentially huge for the treatment of hypertension and Japan has a long tradition of willingness to participate in the battle to lower blood pressure by all means pharmacological. Whilst there are still few data to demonstrate superiority of Direct Renin inhibition over ACE inhibition in long term outcomes, the field of hypertension treatment is still expanding, no doubt in part, driven by consumer demand for the newest agent, and the side-effects, real, important or otherwise of current agents often reported more in anecdote than evidence based format. Novartis has an important role in the area of Renin-Angiotensin System inhibition, and this new approval will do no harm to that reputation and market share.

Better late than never for Novo's new diabetes drug

July 12, 2009

Analysis of:Novo Nordisk's Victoza® (liraglutide) receives marketing authorisation in Europe | www.pipelinereview.com

GLP-1 inhibition is the current vogue in diabetes therapy, led by Lilly's Byetta and the oral DPP-IV inhibitors. Concern about potential pancreatic toxicity of Byetta persists, and Victoza presents a once a day alternative that is potentially more tolerable and more durable than Byetta. The delay in its launch, apparently due to issues relating to delivery moleclues is not new for NovoNordisk, but this agent comes in at a time when the new agents for type 2 diabetes are starting to make headway, and tried and tested products are losing their appeal, even if they are cheap.

Takeda feels the cardiovascular pinch

July 5, 2009

Analysis of:FDA throws up roadblock for Takeda's diabetes drug | www.fiercebiotech.com

After years of riding the crest of the PROACTIVE wave, Takeda now has to take a number and wait to see if Alogliptin can join the DPP-IV bandwagon. Novartis have struggled and taken their foot of the gas in the USA with Vildagliptin, so a CVS clean DPP-IV competitor for Merck's Sitagliptin would be a welcome addition. Whilst other regions will do their own thing, these ripples will still be felt in the UK, Europe and beyond.  From the UK perspective, these drugs are still relatively small players, but if genuine CVS benefits, rather than just helpful neutrality, can be shown, then they have a future.

Onglyza on the verge

July 1, 2009

Analysis of:Onglyza receives positive opinion in Europe for type 2 diabetes | www.pharmabiz.com

Saxagliptin, perhaps the DPP-IV inhibitor with the best name is on the verge of being granted a license in Europe. This will be the third DPP-IV inhibitor available for use in Europe, and is likely to have the same blip in use followed by a prolonged lull whilst the wait for long-term safety data takes place. Like all new drugs for type 2 diabetes mellitus, it has the magic 1% HbA1c reduction, and short-term safety data, but like all the rest from SU's to insulin the long-term data is modest, scant or lacking. As Lantus takes a hit from authors suggesting a cancer link, the time for novel agents which are at least as good as once daily insulin is here. Without evidence of durable effect however, is Saxagliptin or its cousins the answer. Unfortunately the wait might betoo long to bear.

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