As Tecfidera lags, Biogen hopes real-world data can help keep patients on their meds

multiple sclerosis

Biogen’s multiple sclerosis drug Tecfidera has a problem: A relatively high number of patients start the drug, only to stop taking it later. But now, the company has trotted out some real-world data it thinks can help turn that problem around.

The Big Biotech’s blockbuster pill has real-world benefits to be sure; it extended patients’ time to first relapse compared with rivals interferon, Copaxone from Teva and fellow pill Aubagio from Sanofi, according to an analysis of evidence from the global registry MSBase. Tecfidera and Novartis’s Gilenya--the other pill in Tecfidera’s class--posted similar time-to-first-relapse stats.

There’s just one problem: Researchers found that patients treated with Tecfidera were more than twice as likely to discontinue their treatment after 6 months of continuous therapy compared with the Novartis med, pharmaphorum reports. They were 1.4 times more likely to quit Tecfidera treatment after 6 months than those taking interferons, too.

One reason? Gastrointestinal side effects that are “not always easy to get through,” Katie Dawson, Biogen’s US Medical VP, told the publication.

But as a separate real-world analysis showed, patient coaching could be an avenue for sinking that discontinuation rate, Biogen said in a statement. The company has “a lot of information” to help patients “manage the side effects effectively,” Dawson said, and the new data will help it educate patients about short-term side effects as well as Tecfidera’s long-term benefits.

Biogen’s powerhouse pill stormed out of the gate when it first launched in 2013, quickly overtaking the faster-to-market Gilenya and Aubagio. Last year, though, the company announced that Tecfidera's growth trajectory was slowing down. Biogen shares slid and the company axed 11% of its workforce--more than 800 jobs--to save $250 million to throw behind Tecfidera promotion.

Despite that initiative, total prescriptions and new prescriptions both dropped in the week ended September 9, Leerink analysts said in a recent note to clients. Total scripts hit 7,490, representing a week-over-week slide of 11.6%, while new prescriptions sank 15.4% to 1,677.

Meanwhile, Tecfidera could have more challengers heading its way soon. Notorious pharma patent challenger Kyle Bass has been trying to swat down Tecfidera’s patents for months now, and in March he nabbed an inter partes review on the drug at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB).

Bernstein analysts also predicted last year that Gilenya will go generic early--in 2019--with multiple entrants, spelling trouble for the Novartis drug and its rivals, too.

- read Biogen's release
- see pharmaphorum's take

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