UPDATE: European regulatory roundup: Tecfidera, sofosbuvir and more

EU's CHMP offered a recommendation this week for Gilead's sofosbuvir while also agreeing in principle to give Biogen Idec's Tecfidera "new active substance" gives it 10 years of exclusivity.

November 22, 2013

5:00 pm

The European Medicines Agency (EMA) issued highlights Friday of a four-day meeting of the CHMP (Committee for Medicinal Products for Human Use) that took place this week.

CHMP issued a number of opinions with material impacts on high-profile drugs: Biogen Idec’s Tecfidera, ViiV’s Tivicay and BI’s Pradaxa, as well as investigational agents sofosbuvir from Gilead and daclatasvir from BMS. It also offered further guidance on hormonal contraceptives.

The agency said Tecifdera qualifies as a “new active substance.” That designation will grant the drug ten years of exclusivity in the European Union, the company said in a statement today. If Tecfidera is approved, it will be the company’s fourth MS therapy in the EU.

This ruling comes after speculation that dimethyl fumerate—Tecfidera’s active ingredient and a chemical that has been used in the past to treat sofas—may not be granted market exclusivity. As of press time, the regulator had not yet posted a full summary of its decision on Tecfidera.

Regulators also recommended approval of the drug sofosbuvir for use in patients with hepatitis C as the first interferon-tree treatment option for chronic sufferers of the disease. Daclatasvir was recommended for use in HCV with sofosbuvir, for the EMA’s “compassionate use” program.

That program will allow a daclatasvir + sofosubvir combo to be used in patients at high risk of liver failure or death within 12 months. Daclatasvir was granted FDA’s Breakthrough Therapy designation earlier this year. Sofosbuvir’s US PDUFA date is Dec. 8.

The EU agency made rulings for other drugs in the infectious disease category, HIV. ViiV Healthcare’s Tivicay was recommended for use, along with other anti-retrovirals in patients 12 years and older.

Blood thinner Pradaxa was proposed for an extended indication. Regulators removed an age restriction that was previously in place for patients 65 years and older with diabetes mellitus and hypertension.

For Bayer’s hormonal contraceptives Meliane and Yasmin, the regulator ruled that use in preventing unwanted pregnancies outweigh any risk of blood clots. A safety review for the two products was launched earlier this year after a French women sued over alleged side effects.