Astellas/Theravance: FDA Delays Telavancin Approval
Posted on: Wednesday, 24 October 2007, 12:00 CDT
Instead of approving telavancin for the treatment of complicated skin and skin structure infections, the FDA has only issued Astellas and Theravance an approvable letter, requesting further information. Due to the strong competition, with both already marketed and late-stage pipeline drugs in the MRSA sector, this delay could significantly affect telavancin's commercial prospects.
Telavancin, a once-daily injectable antibiotic, has been discovered and developed by Theravance and Astellas for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). An NDA for telavancin was filed in the US in December 2006.
However, instead of finalizing approval for the drug, the FDA only issued an approvable letter, requesting more information in order to resolve current good manufacturing practices (cGMP) compliance issues not specifically related to telavancin at a third-party manufacturer; and submission of revised labeling or re-analyses of clinical data or additional clinical data. At this stage, no detailed information about the FDA's further requests is available; however, potential issues could include concerns regarding the QTc interval or side-effect profile of telavancin as well as non-inferiority margins on MRSA data.
Although telavancin, offering a good efficacy profile and convenient dosing, would be a valuable addition to the MRSA treatment schedule, the delay in approval constitutes a major drawback for the drug. Telavancin is targeting an already crowded market dominated by established competitors including Pfizer's Zyvox (linezolid), Wyeth's Tygacil (tigecycline) and Cubist's Cubicin (daptomycin), combined sales of which across the seven major markets (US, Japan, France, Germany, Italy, Spain, UK) totaled $1 billion in 2006, according to IMS Health.
Furthermore, Telavancin is only one of several new MRSA drugs seeking approval in the MRSA market: Pfizer's Zeven (dalbavancin) is in pre-registration and Arpida's Iclaprim is currently in Phase III trials with an expected launch in 2008. In addition, Johnson & Johnson are extending their antibacterial portfolio for the treatment of infections by drug-resistant pathogens: the company has filed an NDA for ceftobiprole in March 2007 and has recently received approval for Doribax (doripenem).
Until Astellas and Theravance have revealed further details regarding the FDA's concerns, it is hard to predict to what extent the FDA's decision not to approve telavancin at this stage will affect the commercial potential of the drug. However, the delay in approval comes as a blow for Astellas and Theravance considering the strong competition in the MRSA market.
Source: Datamonitor
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