is adding a third medication to its arsenal of drugs for treating attention deficit hyperactivity disorder.
On Friday after markets had closed, the Food and Drug Administration approved Vyvanse, which was developed by
New River Pharmaceuticals
. The drug, for children ages 6 to 12, should become available during the second quarter.
The FDA's action follows by three days Shire's announcement that it wanted more than the marketing deal that it signed with Radford, Va.-based New River in early 2005. Shire is
offering $2.6 billion for the whole company.
FDA approval had been expected on Wall Street. The major benefit for Shire is a drug with key patents that remain effective until June 2023 in the U.S. and June 2024 in the European Union.
Shire's biggest product, the ADHD drug Adderall XR, will be subject to U.S. generic competition in two years. Adderall XR accounted for $864 million, or 48%, of the company's revenue last year, and for 26% of total ADHD prescriptions in the U.S. last year.
As Vyvanse was being developed,
New River claimed it would have a lower potential for abuse than other stimulant-type ADHD drugs, including Adderall XR, which is an amphetamine. If regulators had agreed, Vyvanse, also an amphetamine, would have had a distinct marketing advantage.
But New River and Shire said Friday that the FDA has asked the Drug Enforcement Administration to classify Vyvanse as a Schedule II drug, the same rating as its competitors. The DEA rating system ranges from Schedule I, the highest potential for abuse, to Schedule V, the lowest.
The DEA has issued a preliminary ruling for Vyvanse as a Schedule II drug. It will issue a final ruling after giving the public 30 days to make comments. Until then, Shire won't reveal details of the drug¿s label.
Shire CEO Matthew Emmens said Friday that the label will contain information about patients' experiences and opinions based on clinical trials. This information will "illustrate benefits that differentiate this compound from other ADHD medicines," Emmens said.
Although labels guide doctors and patients, they also serve as marketing tools by identifying what sales representatives and advertisements can say about medications. That's why companies spend considerable time negotiating with the FDA over label language.
Like other ADHD drugs, Vyvanse's label must contain language, recently ordered by the FDA, that alerts doctors and patients to potential risks of cardiovascular damage and psychiatric problems. One question is whether Vyvanse¿s label will feature a "black box warning,' the FDA's strongest alert, about the risks of amphetamine abuse and addiction. Adderall XR's label has such a warning.
Emmens said Vyvanse, known as NRP-104 while it was being developed, will be "our top promotional priority within our ADHD portfolio." In addition to Adderall XR, Shire also sells Daytrana, whose medication is delivered via skin patch. Daytrana was developed by
More Shire ADHD medications could reach the market soon. The FDA is scheduled to rule on SPD465 on May 21. This drug contains the active ingredient in Adderall XR but is being proposed for adults. Adderall XR is prescribed for children as young as six as well as for adolescents and adults. Adderall XR works for 12 hours; SPD465 lasts for 16.
On June 24, the FDA is expected to act on SPD503, an extended release version of a now-generic blood pressure drug called guanfacine. Shire has developed an extended-release version, which it wants to sell as an ADHD treatment to children ages six to 17.