The saying “everything old is new again” may apply to more than just fashion, facial hair and Hollywood remakes of old movies.
It also applies to the pharmaceutical industry.
Research on a new formulation of interferon beta, one of the oldest injectable drugs used to treat multiple sclerosis (MS), found that it works better than placebo in reducing patient relapses and the development of lesions. The updated version of interferon beta was effective even though injections were given every two weeks instead of every other day.
“While this isn’t a brand new blockbuster drug, I do think it will improve compliance and tolerability and therefore positively impact the quality of life of people with MS who take interferon beta,” says study leader Peter A. Calabresi, MD, a professor of neurology at the Johns Hopkins University School of Medicine.
“If it gets FDA approval, this new formulation would allow patients to get the same effect, but instead of the burden of injecting themselves every other day, they only have to do it twice a month. For an MS patient, that’s a huge advance.”
Funding for the study was provided by Biogen Idec (NASDAQ: BIIB), which sells interferon beta under the brand name Avonex. Calabresi serves on Biogen’s Scientific Advisory Board and was a paid consultant to the company until 2011.
The new formulation of interferon beta was modified by attaching polyethylene glycol (PEG) polymer chemical chains that stabilize the drug and make it last longer. Biogen is seeking FDA approval of pegylated interferon beta, which would be sold under the brand name Plegridy.
The yearlong study at Johns Hopkins involved over 1,500 MS patients in 26 different countries. One-third of the patients got a placebo shot every two weeks, one-third got 125 micrograms of pegylated interferon beta shots every two weeks, and the third group got 125 micrograms of pegylated interferon beta-1a once a month, with a placebo shot given at every other visit.
After a year, those who got pegylated interferon beta-1a every two weeks experienced a 36% reduction in the relapse rate compared to the placebo group; the every-four-week group saw a 28% reduction in relapses. MRI scans also revealed 67% fewer new or active lesions in the two-week group, while those injected every four weeks had 28% fewer lesions.
The study, which is being published in The Lancet Neurology, found the beneficial effects of the new drug were comparable to that of the old formulation of interferon beta. But many MS patients stop using the old formula because of its frequent injection schedule and side effects such as flu-like symptoms that last for several hours.
Another disadvantage of the old formula is that about 20% of MS patients typically develop antibodies against interferon beta that eventually neutralize its effects. In the new study, fewer than 1% did.
The new formulation also appears just as safe as the older one, though Calabresi says the flu-like symptoms lasted about 24 hours after each injection in some patients. He called this a trade-off his patients would deem worthwhile.
“The data are very, very clear. We can make things easier for our patients without dangerous side effects just by tweaking what we know to be a safe, 20-year-old drug,” said Calabresi.
MS is an autoimmune disease which attacks the body’s central nervous system and is characterized by the destruction of myelin, the membrane that protects nerves. Once damaged, it inhibits the nerves’ ability to transmit electrical impulses, causing cognitive impairment and mobility dysfunction.
The most common form of the disease, relapsing-remitting multiple sclerosis, is characterized by episodes of worsening neurologic function, followed by periods of remission involving partial or complete recovery. Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. There is no cure for MS. The only therapies available are ones that modify its symptoms.
In 1993, interferon beta became the first drug federally approved for MS. Although its effects are modest in controlling the disease, Calabresi says it works very well in some patients, reducing relapses by about a third and inflammation by more than two-thirds.
An estimated 400,000 Americans suffer from MS and more than two million people worldwide. Before the introduction of oral medications in 2011, the only drugs available to treat MS were injectable. New oral therapies, such as Biogen’s Tecfidera, are rapidly taking market share away from injectable MS drugs.
Regardless of whether they’re injected or taken orally, the cost of MS drugs is soaring. A 2012 study found that the average annual MS specialty drug cost was over $28,000. Worldwide sales of MS drugs generate about $12 billion annually.