One Step Closer To EU Approval...

(RTTNews) - Today's Daily Dose lists the names of drugs that have been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The lone exception is Vanda's antipsychotic medicine Fanaptum, for which the CHMP has rendered a negative opinion.

Read on...

AbbVie's (ABBV) biologic drug Humira just got one step closer to approval for pediatric uveitis patients in Europe - with the European Committee for Medicinal Products for Human Use issuing a positive opinion for the drug.

Humira has been granted positive opinion for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

The European Medicines Agency's final decision for this expanded label indication is anticipated by September.

Humira was approved by the European Medicines Agency for the treatment of non-infectious intermediate, posterior and panuveitis in adults in June 2016.

The drug is also approved for use in adults with moderate to severe active and progressive rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.

Humira is AbbVie's best selling drug, and it netted global sales of $16.08 billion in 2016, up 14.7% over 2015.

ABBV touched a new 52-week high of $75.04 on Friday before closing the day's trading at $74.63, up 0.84%.

Lexicon Pharmaceuticals Inc.'s (LXRX) XERMELO has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use to treat carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

The European Commission is expected to render its final decision on XERMELO in the third quarter of 2017.

XERMELO was approved by the FDA in February of this year.

Lexicon has a license and collaboration agreement with Ipsen SA (IPSEY) to commercialize XERMELO in Europe and other countries outside of U.S. and Japan.

LXRX closed Friday's trading at $16.70, down 0.83%.

Merck's (MRK) blockbuster drug Keytruda has been recommended for approval in Europe by the European Medicine Agency's Committee for Medicinal Products for Human Use in the indication of locally advanced or metastatic urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy, as well as adult patients who are not eligible for cisplatin-containing chemotherapy.

The European Commission's final decision is expected in the third quarter of 2017.

Keytruda is already approved for a number of indications in the U.S. and Europe. The drug's recent approval in Europe was in May for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

Keytruda logged in sales of $584 million in the first quarter of 2017, up 134% over the comparable year-ago quarter.

MRK closed Friday's trading at $62.63, down 0.49%.

A federal jury has ruled in favor of Amphastar Pharmaceuticals Inc. in the patent infringement suit, which was filed by Sandoz and Momenta Pharmaceuticals Inc. (MNTA) over generic version of the blood thinner Lovenox.

The case dates back to September 2011 when Momenta sued Amphastar of infringing its patented control methods for the manufacturing of generic Lovenox.

In its verdict, the Court has ruled that the patent covering methods for the manufacturing of generic LOVENOX was infringed by Amphastar, but invalid and unenforceable.

Commenting on the verdict, Craig Wheeler, President and CEO of Momenta said, "We are disappointed in the jury's verdict and believe the facts and the law do not support these findings. We are considering all available legal options to overturn the verdict, including post-trial motions and appeals."

MNTA closed Friday's trading at $16.80, down 2.61%.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of BAVENCIO as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma, a rare and aggressive skin cancer.

Bavencio is co-developed by Pfizer Inc. (PFE) and EMD Serono, the biopharmaceutical business of Germany's Merck KGaA.

The European Commission's final decision on BAVENCIO is expected in the third quarter of 2017.

In the U.S, Bavencio has won accelerated approval from the FDA for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and urothelial carcinoma.

PFE closed Friday's trading at $33.48, down 0.18%.

Sanofi (SNY) and Regeneron Pharmaceuticals Inc. (REGN), on Friday, announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has recommended approval of Dupixent for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

The European Commission's final decision on Dupixent in the European Union is expected in the coming months.

The FDA approved Dupixent for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis in March of this year.

REGN closed Friday's trading at $515.92, down 1.00%.

The European Medicines Agency's Committee for Medicinal Product for Human Use has recommended against approval of Vanda Pharmaceuticals Inc.'s (VNDA) Fanaptum for the treatment of schizophrenia in adult patients.

The CHMP is of the opinion that the benefits of Fanaptum did not outweigh its risks. Vanda intends to appeal this opinion and request a re-examination by the CHMP.

The drug received approval in the U.S. in 2009, where it is marketed under the brand name Fanapt.

Fanapt net product sales were $74.3 million for the full year 2016, a 13% increase compared to $65.6 million for the full year 2015.

VNDA closed Friday's trading at $16.40, up 0.61%.