2013: Another Big Year Likely for Drug Approvals

Mar 29, 2013
Following a landmark year for FDA drug approvals, 2013 is shaping up to be nearly as big. And again, the list is dominated by specialty medications.
  • Cancer
  • Depression
  • Diabetes
  • Mutiple Sclerosis
  • Pulmonary Hypertension

As I discussed in my post yesterday, 2012 was a landmark year for drug approvals.

 It turns out that 2013 is shaping up to be nearly as big. We could easily see more than 30 new drugs approved, and I expect the ratio to follow recent years, with 60% being specialty medications.

Specialty drugs to treat rare conditions, as well as complex diseases such as cancer, have dominated FDA approvals in recent years. One of the reasons manufacturers focus on specialty is that nearly $90 billion in traditional, brand-name drugs will be going generic within the next five years. Drug companies lost about $32 billion in revenue in 2012 as a result of traditional, brand-name drugs losing patent protection and encountering generic competition.

Specialty Outlook

As in recent years, several new cancer drugs are expected to gain FDA approval in 2013. Several oral formulas as well as targeted therapies that require specific genetic testing before prescribing will result in more treatment options. One example, KadcylaTM, is a new treatment for patients with HER2-positive breast cancer that received approval in February.

Another drug gained FDA approval this week. TecfideraTM (formerly known as BG12), is a new oral drug for the treatment of multiple sclerosis.

New treatments for patients with pulmonary arterial hypertension (PAH) also are expected to get the nod and will be the first new treatments for these patients in five years. Two new drugs are expected in 2013, which is remarkable because treatment options for PAH patients have remained rather steady.

Traditional Forecast

On the traditional side, expected to get the green light from the FDA this year are drugs treating diabetes, chronic obstructive pulmonary disease and depression.

New treatments for Type 2 diabetes are the big story. Five new drugs are expected to gain FDA approval this year, and that means more treatment options and greater competition in this market.

As the most common form of the disease, Type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases diagnosed in the U.S. One drug to watch – InvokanaTM – could be approved any day now. The FDA action date is March 31.

Invokana is a brand-new mechanism for treating Type 2 diabetes. It’s an oral therapy that helps the body excrete excess glucose through the urine rather than absorbing it in the blood. As their disease progresses, patients may need multiple drug therapies to help control their diabetes, and this drug would provide another option.

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