The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted positive opinions for marketing authorisation to five drugs in March.
IHS Global Insight perspective | |
Significance | The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency held its monthly meeting on 18–21 March. The CHMP issued positive opinions on five new drugs for marketing approval in the European Union. In addition, the committee has recommended extensions to therapeutic indications on four products already authorised for commercialisation in the EU. |
Implications | The five drugs approved are indicated for treatment of MS, HIV-1, and leukaemia. |
Outlook | The positive opinions are required in order to obtain final approval from the European Commission. The approval from the EC will enable the commercialisation of the drugs in all EU member states, as well as Iceland, Liechtenstein, and Norway. |
During its March meeting, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) issued five positive opinions for new pharmaceutical products. In addition, the CHMP has also issued four positive opinions for the extension of therapeutic indications for drugs already commercialised in the European Union. Full text available here.
Positive recommendations for new drugs | ||
Drug | Company/organisation | Indication |
Aubagio (teriflunomide) | Sanofi (France) | Treatment of adult patients with relapsing remitting multiple sclerosis (MS) |
HyQvia (Human normal immunoglobulin) | Baxter (US) | Replacement therapy in adults (> 18 years) in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiency; and IgG subclass deficiencies with recurrent infections. Replacement therapy in adults (> 18 years) in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. |
Iclusig (ponatinib) | Ariad Pharma (US) | Treatment of adult patients with: – chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation; and – Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. |
Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil) | Gilead Sciences International (US) | Treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. |
Tecfidera (dimethyl fumarate) | Biogen Idec (United States) | Treatment of adult patients with relapsing remitting multiple sclerosis. |
Positive opinions for extensions | ||
Drug | Company/organisation | Indication |
MabThera (rituximab) | Roche (Switzerland) | In combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA). |
Soliris (eculizumab) | Alexion (United States) | Treatment of in adult and children with: - Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit of Soliris in the treatment of patients with PNH is limited to patients with history of transfusions. - Atypical haemolytic uremic syndrome (aHUS) |
Viread (tenofovir disoproxil fumarate) | Gilead Sciences | Treatment of chronic hepatitis B in adults with evidence of lamivudine-resistant hepatitis B virus. |
Xarelto (rivaroxaban) | Bayer (Switzerland) | Xarelto 2.5mg, co-administered with acetylsalicylic acid (ASA), alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers |
In addition to the above mentioned opinions, the CHMP issued a positive recommendation on informed consent application for Stayveer (bosentan monohydrate; Marklas, Netherlands) for the treatment of pulmonary arterial hypertension and digital ulcer disease. The CHMP granted negative recommendations on two new drugs, Defitelio (defibrotide; Gentium, Italy) and Labazenit (budesonide/salmeterol; Laboratoires SMB, Belgium). With regard to Defitelio, the CHMP highlighted problems with the prevention study, as for example with the documentation and data provided by Gentium, as well as with the treatment study which included a scarce number of patients. Furthermore, the CHMP granted a negative opinion to Labazenit as the clinical study with budesonide was not satisfactory in demonstrating Labazenit's anti-inflammatory effect. Finally, the CHMP has also re-examined Genzyme (subsidiary of Sanofi, France)'s Kynamro (mipomersen) and issued a new negative recommendation on the drug as the concerns linked to the refusal issued in December 2012 were not addressed in a satisfactory manner by the manufacturer (see United States - France - Europe: 17 December 2012: CHMP issues negative opinion on marketing authorisation application for Kynamro).
Outlook and implications
The outcomes of the March meeting of the CHMP are encouraging for Sanofi as its MS treatment Aubagio received a positive opinion. If the CHMP decision is confirmed by the European Commission, the drug will be authorised for commercialisation in Europe. The drug that received a negative opinion from the Australian Pharmaceutical Benefits Advisory Committee in December is currently under review by the US FDA (see Australia: 21 December 2012: Australia's PBAC releases November outcomes report, Xarelto not recommended and United States - France: 29 January 2013: US FDA accepts Lemtrada for treatment of MS for review).
In addition, positive results emerged from the CHMP meeting for the once-daily tablet for HIV-1 treatment Stribild, manufactured by Gilead Sciences, which has already received marketing authorisation in a number of countries worldwide, including the US, Canada, South Korea, and Australia. The granting of marketing authorisation in the EU, if ratified by the Commission, will offer Gilead the opportunity to expand its business in the regional pharmaceutical market.
The positive opinion granted to Biogen's Tecfidera for the commercialisation of the MS treatment may represent a major opportunity for the US company. In fact, the drug is administered in a pill form, as opposed to current injected drugs. This may offer significant opportunities of expansion in the MS segment of the market for Biogen through this advantage in terms of convenience in its administration. In addition, Biogen has already commercialised two MS treatments, namely Avonex (interferon beta-1a) and Tysabri (natalizumab).