FDA staff backs J&J’s Xarelto for heart condition

Posted under acute coronary syndrome, atrial fibrillation, Blog, Companies, Diagnostics, FDA, Funding, heart drug, Johnson & Johnson, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, Startups, Universities, Videos, Xarelto by Ryan McBride

As Johnson & Johnson ($JNJ) builds the blockbuster pedigree of Xarelto, an FDA reviewer has given the thumbs-up to the new clot-busting drug as a treatment for the heart problem known as acute coronary syndrome. The staffers' recommendation of approval comes ahead of Wednesday's advisory committee meeting on the expanded use of J&J and Bayer's Xarelto in ACS patients.

While Xarelto was associated with steep rises in bleeding risks, a 2.5-milligram dose of the drug cut down heart attacks and strokes 15% compared with placebo in patients studied, Bloomberg reported. On Wednesday, the committee of non-agency advisers to the FDA will weigh in on whether those risks and benefits merit the new approval for the drug, which has already gotten the green light to stymie strokes in patients with atrial fibrillation and in patients who undergo knee and hip surgeries.

Yet Reuters chose to bore into how the FDA staff review pointed to a lack of data to support Xarelto's ability to reduce heart attacks and strokes, indicating that this raises questions about the drug in ACS patients.

Bleeding risks are common among blood-thinning drugs, and analysts don't expect this safety issue to thwart approval of Xarelto to combat ACS, which causes clotting that impedes blood flow to the heart. With the ACS indication, Xarelto could eventually bring in an additional $400 million to $700 million annually, according to analysts at Cowen. And the expanded use could give the therapy a new leg up among next-generation blood-thinners such as Boehringer Ingelheim's Praxada and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis.

"Our clinical consultants view Xarelto's reward/risk profile in ACS patients as positive, and predict an approval recommendation," analysts at Cowen wrote in a note to investors on Friday. "They also believe that Xarelto's mortality benefit in ACS is an important differentiation relative to Pradaxa and warfarin, and should bolster Xarelto's adoption across the atrial fibrillation patient population."

- read Bloomberg's story
- see Dow Jones Newswire's report
- and Reuters' take

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User fee legislation promises better access, speedier reviews at FDA

Posted under Biologics, biosimilars, Blog, Companies, Diagnostics, FDA, Funding, Medical Devices, Medical Supply, PDUFA, Pharmaceuticals, Regulatory, Startups, Universities, user fee legislation, Videos by John Carroll

Bipartisanship is a rare sight in Congress these days, but a top tier of politicos in Washington D.C. says they've managed to hit the sweet spot with new user fee legislation being taken up by the Senate this week. That note of harmony is likely to sing the bill through to passage, triggering promises of significant improvements related to FDA access and cooperation in drug and device development.

As noted by Bloomberg today, the PDUFA reauthorization bill of 2012 calls for a 6% bump in fees from drugmakers. There's also a $1.5 billion contribution from generic drugmakers in exchange for a commitment to shorten the prolonged review times--30 months on average--generics face at the regulatory agency. Devicemakers are doubling down on their fees, looking for easier access to regulators as they plot development programs. And for the first time there's a new source of fee income that will flow from the fledgling biosimilars industry, which is developing the first generation of biologic copies.

The biopharma industry has been hammering away at the FDA for months now, accusing the agency of dragging their feet on drug reviews or blindsiding them with unexpected challenges. Under PDUFA 2012 regulators promise to commit to offering more meetings and advice on trial designs with an eye to speeding the approval process. 

"Drug developers feel there really is value in getting FDA's perspective early to avoid surprises in an application review," Catalyst Healthcare Consulting President Nancy Bradish Myers tells Bloomberg. By getting more access early on, drugmakers believe they can improve the odds of an initial approval, without having to go back to the drawing board to gather more data. 

Dig down into the legislation, and you'll also find a commitment to speed approvals for new drugs that address serious or life-threatening diseases, offering a willingness to use surrogate endpoints to extend approvals rather than waiting for data on some of the gold standard endpoints that have been in place for years.

It's unlikely, though, that the legislation's commitment to greater transparency and efficiency at the agency will translate into broad happiness in the industry with the FDA. Hurt by the steadily rising sums spent on drug development and frequently stung by caustic regulatory reviews, the industry is always likely to have a wary take on regulatory reviews and cooperation. And faced with a history of safety issues related to new drugs, the FDA is likely to continue to remain skeptical when it hears industry criticism.   

- here's the story from Bloomberg

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Study: FDA outpaces the EMA on drug reviews, new approvals

Posted under Blog, Companies, Diagnostics, FDA, Funding, Kathleen Stratton, Medical Devices, Medical Supply, PDUFA, Pew Charitable Trusts, Pharmaceuticals, Regulatory, Startups, Universities, Videos by John Carroll

After cranking up as much pressure as the industry could muster over the last year, lawmakers have been queuing up new laws aimed at speeding the FDA's review of drugs while gaining fresh pledges from regulators on flexibility and swifter decision-making. But a new study published in The New England Journal of Medicine concludes that an objective look at the data scuttles the whole notion that regulators in the U.S. are too slow when it comes to saying yes to a new therapy.

Investigators looked at every approval handed out for a new chemical entity between 2001 and 2010. They found that FDA regulators were on average 15% faster than either the EMA or Health Canada. Of the 225 drug applications studied, the average review time hit 322 days at the FDA. And the U.S. agency was the first to approve two of every three new drugs filed with both the FDA and the EMA.

"This allows us to focus on the important question of whether there are real barriers to drug innovation in the U.S.," Kathleen Stratton of the Pew Charitable Trusts told the AP. "But it's clear from this study that the speed at which the FDA reviews drug applications is not one of them." Pew, a noted advocate for public safety, funded the study undertaken by investigators at Yale and the Mayo Clinic.  

It's unlikely that many executives in the biopharma industry would agree with that remark. Negotiations over the new PDUFA law includes pledges of speedier reviews and more predictable responses. That came after a long and intense campaign in which industry leaders moaned about the risky and enormously expensive drug development process. And some might argue that just because U.S. regulators are faster than colleagues in Europe and Canada, that doesn't make them as fast as they should be.

One other point: The review was limited to approved drugs, excluding the time involved for drugs that were ultimately red-flagged by the agency. 

- here's the AP report

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Payers likely to throw up hurdles to Pfizer’s new RA drug

Posted under Blog, Companies, Diagnostics, FDA, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Rheumatoid Arthritis, Startups, tofacitinib, Universities, Videos by john

You know that old adage: The one with the gold makes the rules? For the latest exhibit, look no further than Pfizer's ($PFE) anticipated rheumatoid arthritis treatment tofacitinib. After an FDA advisory panel voted in favor of the drug last week, Reimbursement Intelligence surveyed 30 big payers, asking how they'd manage access to the new treatment if it wins final approval. More than three-fourths of payers said they'd require patients to fail on at least one TNF inhibitor, such as Abbott Laboratories' ($ABT) Humira or Johnson & Johnson's ($JNJ) Remicade, before turning to Pfizer's new med. What's particularly striking about these survey results is that the payers' attitudes changed after the AdComm meeting. Report