FDA Approvals Expected for 2014

Mar 27, 2014
2014 is shaping up to be another blockbuster year for specialty drug approvals.
  • Allergies
  • Cancer
  • Diabetes
  • Hepatitis C
  • Inflammatory Conditions
  • Mutiple Sclerosis

As I discussed in my post yesterday, specialty drugs dominated 2013 drug approvals.

With several new cancer drugs and new all-oral treatments for hepatitis C expected to gain approval from the Food and Drug Administration, 2014 is shaping up to be another blockbuster year for specialty drugs.

Specialty drugs to treat rare conditions and complex diseases such as cancer have accounted for the majority of FDA approvals for the past three years, as drug manufacturers devote more time and money to developing more specialized treatments. While the majority of drugs expected to gain approval this year will be specialty drugs, several new traditional drugs to treat diabetes, allergies and pain will present new treatment options for millions of Americans.

More Approvals, More Competition

In late 2013, the FDA approved two new oral drugs – Olysio® and Sovaldi® – to treat different genotypes of hepatitis C, which affects about 2.7 million Americans. Sovaldi®, the first drug approved as part of an all-oral regimen for hepatitis C, carries with it an $84,000 price tag for a course of therapy. But the pipeline of drugs expected to gain approval this year will mean increased competition in this market.

Before the end of this year, two new all-oral regimens for genotype 1 are expected to be approved by the FDA. Genotype 1 is the most common type of hepatitis C, representing about 75% of cases, or 2.4 million patients. Gilead’s ledipasvir/sofosbuvir is a combination tablet that is taken once daily for eight weeks to 12 weeks for patients with genotype 1. AbbVie has developed a three-drug oral regimen for genotype 1. Both new treatments are expected to reach blockbuster status.

Among traditional drugs, the treatment of Type 2 diabetes also will see increased competition. In March 2013, the FDA approved Invokana®, a new oral therapy that helps the body excrete excess glucose through the urine rather than absorbing it in the blood. A drug with a similar mechanism is making headlines this year. The FDA approved Forxiga® in January. A third similar drug, empagliflozin, was recently delayed by the FDA, but final approval could yet occur in 2014.

In just over a year, the FDA will approve three products with the same mechanism to treat Type 2 diabetes. These drugs will impact the lives of millions of Americans.

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. Three additional diabetes treatments – AfrezzaTM, dulaglutide and Syncria® – are also expected to gain FDA approval this year.

Oncology Outlook

Several breakthrough cancer therapies may reach the market in late 2014 or early 2015. Following the trends of recent years, several drugs designated as oral treatments are expected to gain approval.

Ceritinib is an oral medication to treat certain patients with non-small cell lung cancer. This drug will require a pharmacogenetic test to identify appropriate candidates for therapy. Palbociclib, a new oral treatment to be used in combination with another drug, FemaraTM, targets advanced hormone-sensitive breast cancer and is expected to be a blockbuster medication. Idelalisib is an oral cancer drug expected to be approved this year to treat chronic lymphocytic leukemia and non-Hodgkin lymphoma. Two new breakthrough immunotherapies also are expected to reach the market in late 2014 or early 2015.

Nivolumab and MK-3475 are infused immune checkpoint inhibitors that cause the body to elicit an immune response to attack the cancer. MK-3475 may be approved in late 2014 or early 2015 for advanced melanoma. Nivolumab will likely be approved early next year for non-small cell lung cancer.

Additional Traditional Highlights

The FDA currently is reviewing three allergy immunotherapies that are administered orally, specifically under the tongue, for the treatment of various pollen allergies such as grass and ragweed.

If approved, these products will compete with the traditional allergy shots, which are injections administered in a healthcare provider’s office. Because these are oral therapies, patients can self-administer these regimens to help relieve or lessen their symptoms throughout allergy season.

For pain management, the FDA recently approved XartemisTM, the first extended-release formulation of oxycodone and acetaminophen. This is the only extended-release hydrocodone-acetaminophen combination available for treating acute pain. It provides a new option where previous treatments may not have helped.

Later this year, TarginiqTM ER may also gain approval. This drug combines oxycodone and naloxone for patients with severe chronic pain. The naloxone component in this combination makes the drug more difficult to abuse.

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