New Drug Approvals

Innovation Pays: Priority Drugs Drove Novel 2011 Approvals To New Heights / The new molecular entity and novel biologic class of 2011 isn’t just the largest since 2004 – CDER also posted near-perfect on-time review performance while maintaining healthy rates of first-cycle approvals and a low 15 month average time to approval, thanks to a high level of innovation in the novel product candidates. / Pharmaceutical Approvals Monthly January 2012

Erwinaze And The Blessings Of A Missed PDUFA Goal / CDER missed one user fee goal for action in its 2011 novel approvals – EUSA Pharma’s Erwinaze – and running long allowed the agency and sponsor to find a work-around to a clinical problem that could otherwise have entailed time-consuming new investigations. / Pharmaceutical Approvals Monthly January 2012

Industry Can Do More To Facilitate Approval Efficiency – CSDD / Designing simple and efficient protocols that cut down on the time it takes to get marketing applications submitted to FDA is key to both economic and regulatory success for drug makers, the Tufts Center for the Study of Drug Development suggests in its 2012 Outlook report on trends in the industry. Currently, large and already expensive Phase III registration trials require on average nearly three amendments with over eight changes each, according to Tufts’ CSDD. / Pharmaceutical Approvals Monthly January 2012

New Molecular Entities Approved In 2011 / Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research. / Pharmaceutical Approvals Monthly January 2012

Biologics Approved In 2011 / Annual listing of novel biologic entities approved by FDA. / Pharmaceutical Approvals Monthly January 2012

FDA Policy

Senior CDER Management Panel Could Facilitate Novel Therapy Approval / CDER Director Janet Woodcock is creating an executive-level forum to deliberate medical policies, including those needed to smooth drug reviews. She envisions stakeholder input on topics for discussion by the panel. / Pharmaceutical Approvals Monthly January 2012

Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program / Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system. / Pharmaceutical Approvals Monthly January 2012

Drug Review Profile

Multiple Aspirin Dose Analyses Reassured FDA On Brilinta’s U.S. Efficacy / The consistency of numerous analyses supporting a negative interaction between ticagrelor and high-dose aspirin, as used in the U.S., helped overcome FDA’s initial reluctance to approve AstraZeneca’s platelet inhibitor without a new trial. / Pharmaceutical Approvals Monthly January 2012

Shades Of Prasugrel: Brilinta Review Felt The Effects Of Effient’s Experience / FDA’s review of AstraZeneca’s platelet inhibitor ticagrelor was tinged by the agency’s earlier evaluation and delayed approval of Lilly/Daiichi’s prasugrel for acute coronary syndromes. / Pharmaceutical Approvals Monthly January 2012

Brilinta Review Sparks War Of Words Between FDA Cardio-Renal Division’s Marciniak, Stockbridge / The ticagrelor NDA ignited strong opinions from the cross-discipline team leader about sponsor AstraZeneca’s conduct, drawing a forceful response from the review division director. / Pharmaceutical Approvals Monthly January 2012

Brilinta Clinical Development / A timeline chronicling the development history of AstraZeneca’s ticagrelor. / Pharmaceutical Approvals Monthly January 2012

Brilinta Reviewers / FDA staff that participated in the review of AstraZeneca’s anticoagulant. / Pharmaceutical Approvals Monthly January 2012

Pipeline Updates

Lilly To Give High-Risk Alzheimer’s Drug “Every Chance,” Lechleiter Says At JP Morgan / Lilly is relying heavily on biomarkers to help its Alzheimer’s disease-modifying drug solanezumab progress, executives tell a crowd of analysts at JP Morgan. Though the project is high risk, Lechleiter pointed to the company’s full pipeline and success of diabetes portfolio as signs of Lilly’s momentum. / Pharmaceutical Approvals Monthly January 2012

R&D News

Regulatory Update For Qnexa Could Signal A Change In The Obesity Landscape / New developments for Vivus’ weight loss drug Qnexa may mean that the regulatory environment for obesity treatments could be improving. / Pharmaceutical Approvals Monthly January 2012

FDA Performance Tracker

Biologics Approved In 2012 / FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research on Oct. 1, 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins. / Pharmaceutical Approvals Monthly January 2012

Estimated FDA User Fee Review Goals For Pending NDAs/BLAs / Estimated user fee goals for FDA action on publicly disclosed NDAs, BLAs and efficacy supplements are calculated based on the date of receipt and assignment to standard or priority review. Resubmissions with significant new data or analyses have a 6-month goal. / Pharmaceutical Approvals Monthly January 2012

“Complete Response” Letters / FDA stopped issuing “approvable” and “not approvable” letters in favor of “complete response” letters on Aug. 11, 2008. The following chart lists “complete response” actions that were recently announced, as well as still-pending “approvable” and “not approvable” actions. / Pharmaceutical Approvals Monthly January 2012

December Full Approvals / Full approvals of NDAs and BLAs. / Pharmaceutical Approvals Monthly January 2012

December Supplemental Approvals / Chart lists efficacy supplements and labeling supplements selected by the editors of “Pharmaceutical Approvals Monthly.” This is not a comprehensive list of all supplemental approvals. / Pharmaceutical Approvals Monthly January 2012

December ANDA Approvals / Product Sponsor Date Approved Application No. Methylphenidate HCl 20 mg, 30 mg and 40 mg, extended-release caps. / Pharmaceutical Approvals Monthly January 2012

Current Class Of Risk Evaluation & Mitigation Strategies / Here is a general outline of the REMS FDA has mandated so far, as well as a listing of drugs where it has been announced that REMS are being developed or drugs with safety issues that could invoke a REMS. / Pharmaceutical Approvals Monthly January 2012