Novo Nordisk
(
NVO
) recently announced that it has received approval in the EU
(covering all 27 states) for its diabetes treatments, Tresiba
(insulin degludec) and Ryzodeg (insulin degludec/insulin
aspart).
The EU approval for Tresiba and Ryzodeg was expected as both
drugs had received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) in the EU in Oct 2012
.
Under 'treat to target' studies, Tresiba was compared to
insulin glargine and Ryzodeg was compared to NovoMix, and both
showed a significantly lower risk of overall and nocturnal
hypoglycemia, while successfully achieving equivalent reductions
in HbA1c.
Ryzodeg is a soluble formulation of Tresiba (insulin degludec)
and NovoRapid (insulin aspart - known as NovoLog in the
US). Tresiba and Ryzodeg will be available in Novo
Nordisk's latest prefilled insulin pen named FlexTouch in
Europe.
Novo Nordisk is planning to launch Tresiba first and Ryzodeg a
year later. Tresiba will initially be launched in the UK and
Denmark in the first half of 2013 and in other European markets
throughout 2013 and 2014.
We note that Ryzodeg and Tresiba are currently under US Food
and Drug Administration (FDA) review for the treatment of
diabetes in adults. The candidates received a positive vote for
approval from an FDA Advisory Committee in the US in Nov 2012. We
expect approval shortly.
Additionally, Novo Nordisk is seeking regulatory approval for
Tresiba and Ryzodeg in Canada, Switzerland and several other
countries. Ryzodeg and Tresiba are also approved in
Japan.
Our Take
We are pleased with the company's efforts to strengthen its
presence in the diabetes market. Novo Nordisk carries a Zacks
Rank #2 (Buy).
Other pharmaceutical companies performing well are
Salix Pharmaceuticals
(
SLXP
) and
Valeant Pharmaceuticals
(
VRX
), both of which carry a Zacks Rank #1 (Strong Buy).
Additionally,
BioCryst Pharmaceuticals
(
BCRX
) is also performing well and carries a Zacks Rank #2.
BIOCRYST PHARMA (BCRX): Free Stock Analysis
Report
NOVO-NORDISK AS (NVO): Free Stock Analysis
Report
SALIX PHARM-LTD (SLXP): Free Stock Analysis
Report
VALEANT PHARMA (VRX): Free Stock Analysis
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