Key Developments For Pfizer Inc.
Pfizer Inc. (PFE) (NYSE Arca)
Pfizer Told To Pay $28 Million Damages In Prempro Case-Reuters
Reuters reported that a Philadelphia jury has ordered Pfizer to pay $28 million in punitive damages to a breast cancer survivor who had used the Company's hormone replacement drugs for 11 years. That followed a $6.3 million award the jury ordered Pfizer to pay in compensatory damages after deciding that the drugs Premarin, Prempro and Provera contributed to her cancer and that the drugmakers failed to adequately warn about the risks associated with the medicines.
Pfizer Receives FDA Approval For Geodon (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults
Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Geodon (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.
FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For Treatment Of Pulmonary Arterial Hypertension
Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Revatio (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy. The efficacy of Revatio has not been adequately evaluated in patients taking bosentan concurrently. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio Tablets but who are temporarily unable to take oral medication.
Pfizer Announces FDA Advisory Committee Finds Data Support Claim That SPIRIVA HandiHaler Reduces COPD Exacerbations
Pfizer announced that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA HandiHaler (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD). The advisory committee also voted affirmatively that data from the UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium) trial adequately addressed the potential safety concern for an increased risk of stroke (11 yes to 1 no) or adverse cardiovascular events (11 yes with 1 abstention). This is consistent with the current product label. The advisory committee makes recommendations to the FDA, which the agency considers in its final decision. The advisory committee reviewed pivotal data from a six-month trial (Veterans Affairs Study, 205.266) of 1,829 COPD patients and secondary endpoints from a four-year trial (UPLIFT Study, 205.235) of approximately 6,000 COPD patients. Although UPLIFT did not meet its primary endpoint, the study supports data from the VA trial showing that SPIRIVA HandiHaler consistently reduced the risk of exacerbations in COPD patients.
Pfizer Says FDA Advisory Committee Finds Data Support Safety And Effectiveness Of Prevnar 13 Vaccine For Prevention Of Invasive Pneumococcal Disease In Infants And Young Children
Pfizer announced that the U.S. Food and Drug Administration`s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children. The Company is seeking an indication for active immunization of infants and toddlers for the prevention of invasive disease (including sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema) and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes. The FDA will consider the Advisory Committee`s votes and discussion in its review of the Biologic License Application (BLA) for Prevnar 13, which has an action date of December 30, 2009. The Advisory Committee`s votes in support of Prevnar 13 were based on a review of the data from 13 core Phase III studies involving more than 7,000 children. The Advisory Committee`s discussion included consideration of the multiple immunogenicity endpoints in the trials. The Committee agreed that the totality of the data supported the effectiveness of Prevnar 13 for the prevention of invasive pneumococcal disease in infants and young children. The Committee also discussed the Prevnar 13 safety profile and agreed that the data were adequate to support its safety.
