Wednesday, July 30, 2008

New Drug Approvals at the Half: 2008 Looks A Lot Like 2007, And That Isn’t Good

So do you want the good news or the bad news?

Let's start with the bad. So far, the number of new molecular entities and novel biologics approved by the Food & Drug Administration in the first half of 2008 is actually lower than it was at this time last year. FDA approved six NMEs by the end of June 2008, one less than the seven NMEs approved by the mid-point of 2007.

And history suggests the second half will look kind of like the first. In recent years, roughly half of the yearly total of NME approvals fall between January and June. In 2007, seven of 16 NMEs were approved by June 30; in 2006, nine of 18 fell in the first six months; and in 2005, seven of 18 NMEs were approved halfway through the year. (For more analysis of FDA’s approval performance at the half, see the July issue of Pharmaceutical Approvals Monthly.)

Given that 2007 ended up being quite possibly the worst year ever for innovative pharmaceutical launches, those are not trends anyone should be excited about. Only 16 NMEs made it through the agency last year, the lowest single-year total in a quarter century--which is before the modern generic drug industry took shape and made new molecules so vital to the health of brand name companies.

So what's the good news? Well, despite the slow start andFDA's recent history of slow finishes, we would be willing to be that the agency will in fact beat last year's NME total.

Why? First off, the agency has at least 30 pending applications for NMEs with user fee deadlines that fall during the second half of the year. (Want the list? Click here to see it, courtesy of Pharmaceutical Approvals Monthly.)

Of course, FDA has officially decided that it no longer has to meet the official user fee deadlines – given the overload of work stemming from the new drug safety legislation on an already strained staff. That certainly complicates any predictions for the rest of the year--but it also means FDA has a handful of applications that are overdue for action. And, it looks to us like the trend is for missed deadlines to end in approvals, rather than requests for more data and new review cycles.

User fee goals have been missed for three NMEs under review by the Division of Cardiovascular and Renal Products alone this year: Cardiome/Astellas’ Kynapid (vernakalant) and Solvay’s Pulzium (tedisamil), both anti-arrhythmics with user fee goal dates in mid-January, and The Medicines Company’s Cleviprex (clevidipine) for acute hypertension in May.

More recently, Theravance announced that the July 21 user fee date for its antibiotic televancin was passing without FDA action. Amgen also announced that the user fee deadline for Nplate was among the cohort of drugs where FDA was consciously missing the PDUFA date (after accidentally releasing a press release that the thrombocytopenia product was being approved).

That means FDA has at least five pending applications where an answer is overdue. We're betting that most of those will end up approved at some point this year.

Then there is the impact of one of the biggest changes to FDA’s review authorities under the new law: the creation of mandatory Risk Evaluation & Mitigation Strategies. Thus far, FDA has used the REMS to breathe life into drugs that were stuck at the agency for years.

We'll talk more about those trends in some upcoming posts, but the bottom line is that we still expect the NME tally this year to come in ahead of last year.

Still, let's keep some perspective: if by some miracle FDA approves all 30 pending NMEs this year, it will end up with a total of 36 overall. More than double last year's tally--but just an average year for the 1990s.

Sadly for the innovative industry, its clear that the best to hope for this year is to recovery from abysmal to the merely dreadful.

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