Sanofi’s Humenza poised to be Europe’s fifth swine flu vaccine
pharmafile | February 22, 2010 | News story | Sales and Marketing | Sanofi Pasteur, Tyverb, Zeftera, swine flu
Sanofi Pasteur’s Humenza is set to become the fifth swine flu vaccine in Europe after gaining the support of a key regulatory committee.
The Committee for Medicinal Products for Human Use (CHMP) recommended the vaccine for European approval under its emergency, fast-track pandemic procedure.
In a related move, the Committee has given its second positive opinion on compassionate use for flu, in this case for IV Zanamivir.
This is an intravenous formulation of GlaxoSmithKline’s zanamivir, used to treat critically ill patients with a life-threatening condition due to pandemic or seasonal flu.
The CHMP has also given a conditional green light to GSK’s Votrient (pazopanib), for patients with advanced renal cell carcinoma (RCC).
But it is waiting for comparative data on the drug versus one of the current standard first-line treatment options, Pfizer’s Sutent (sunitinib), and will review new information within a year.
Meanwhile the CHMP has refused to okay Janssen-Cilag International’s Zeftera (ceftobiprole medocaril), an antibiotic to treat patients with skin and soft tissue infections.
However, it did agree following a review that the benefits of the same manufacturer’s Regranex (bercaplermin) outweigh its risks for diabetic patients with long-term skin ulcers.
It said Regranex should be contraindicated as a precautionary measure in patients who have any pre-existing cancer.
Two generics have received positive opinions, the first being Sun Pharmaceutical Industries Europe’s Docefrez (docetaxel).
This is a version of Sanofi’s Taxotere, authorised in the EU for half a dozen cancers including breast and non-small cell lung cancer.
Teva Pharma’s Raloxifene Teva (raloxifene hydrochloride), a generic version of Lilly’s Evista, to treat osteoporosis in postmenopausal women, has also been approved.
Meanwhile the indications on two drugs authorised in Europe have been extended.
GSK’s Tyverb (lapatinib) can now be used to treat patients with breast cancer whose tumours overexpress HER2 (ErbB2).
And Cholestagel (colesevelam), made by Genzyme Europe, can now be combined with Merk’s Zetia (ezetimibe), with or without a statin, in adult patients with primary hypercholesterolaemia.
The CHMP has also ruled that Teva Pharma’s and Orion Corporation’s 75 mg film coated tablet versions of Sanofi’s heart drug Plavix (clopidogrel) should be granted marketing authorisation.
There had been concerns over the use of a clopidogrel base as the active substance, which had to be stabilised using the antioxidant butylated hydroxyanisole.
But the Committee said the antioxidant did not pose a serious risk to patients and that the benefit-risk profile was positive.
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