PIPELINE WATCH - Seven Approvals, Nine Positive Opinions And Two Launches
This article was originally published in Scrip
Executive Summary
This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.
This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.
| Lead Company | Partner Company | Drug | Indication | Market | Comments |
| REGULATORY APPROVAL | |||||
| Pfizer Inc. | Celltrion Inc. | Inflectra (infliximab-dyyb) | Crohn's disease, ankylosing spondylitis, psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis | US | A biosimilar of Janssen Biotech's Remicade. Rights to the biosimilar acquired by Pfizer when it acquired Hospira in Sept. 2015. |
| Gilead Sciences Inc. | - | Descovy (emtricitabine, tenofovir alafenamide) | HIV | US | A fixed-dose combination in a oral tablet, to be used as a treatment backbone when paired with other antiretrovirals. |
| SUPPLEMENTAL REGULATORY APPROVAL | |||||
| Bristol-Myers Squibb. & Co. | - | Opdivo (nivolumab) | advanced renal cell carcinoma | EU | After prior therapy in adults. It is the first agent to show a significant improvement in overal survival in advanced renal cell carcinoma. |
| Bristol-Myers Squibb. & Co. | Ono Pharmaceutical Co. Ltd. | Opdivo (nivolumab) | non-small cell lung cancer (NSCLC) | South Korea | In patients with locally advanced or metastatic NSCLC refractory to prior chemotherapy. It is already approved for melanoma. |
| Novartis AG | - | Revolade (eltrombopag) | pediatric chronic immune (idiopathic) thrombocytopenic purpura (ITP) | EU | For children aged one year or above with chronic ITP. The product was acquired from GSK in 2015 and has been approved for use in adults since 2010. |
| Boehringer Ingelheim | - | Giotrif (afatinib) | squamous cell lung cancer | EU | In patients whose disease has progressed on or after platinum chemotherapy. It is already approved for EGFR mutation positive NSCLC. |
| Pharming Group NV | Swedish Orphan Biovitrum (Sobi) | Ruconest (conestat alfa) | hereditary angioedema attacks in adolescents | EU | It is already approved for the same indication in adults. |
| SUPPLEMENTAL REGULATORY FILING ACCEPTED | |||||
| Mundipharma | Skyepharma PLC | flutiform K-Haler (fluticasone plus formoterol) | asthma | EU | A breath-actuated inhaler version of flutiform, submitted to the UK's MHRA under the decentralized procedure. |
| ORPHAN DRUG DESIGNATION | |||||
| Sellas Life Sciences Group | - | galinpepimut-S | acute myelogenous leukemia (AML) | EU | A potentia WT1 cancer vaccine for AML and malignant pleural mesothelioma, in Phase II. |
| CHMP POSITIVE OPINION ON FIRST APPROVAL | |||||
| GlaxoSmithKline plc | - | Strimvelis (GSK2696273) | severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID) | EU | A stem cell gene therapy, where autologous CD34-positive cells are transduced to exprese ADA. For patients with no suitable stem cell donor. |
| GlaxoSmithKline plc | Amicus Therapeutics Inc. | Galafold (migalastat) | Fabry disease | EU | An oral small-molecule chaperone for use in patients with one of 269 Fabry-causing gene mutations |
| Johnson & Johnson Inc. | Genmab A/S | Darzalex (daratumumab) | relapsed and refractory multiple myeloma | EU | In the EU's accelerated assessment program, conditional approval recommended while Phase III stuedies are completed on its use in combination with standard therapies. |
| Samsung Bioepis (Samsung BioLogics and Biogen jv) | Biogen | Flixabi (infliximab) | rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis | EU | A biosimilar of Remicade, the second developed by Samsung Bioepis to receive an EU positive opinion. |
| AstraZeneca PLC | - | pandemic live attenuated influenza vaccine | flu prophylaxis | EU | Conditional approval recommended for a vaccine that can be quickly updated later with the specific pandemic strain. |
| Actelion Pharmaceuticals Ltd. | - | Uptravi (selexipag) | pulmonary arterial hypertension | EU | A procedural re-adoption of a positive opinion given on Jan 28, 2016, following clarifications requested by the European Commission. |
| CHMP POSITIVE OPINION ON SUPPLEMENTAL APPROVAL | |||||
| Janssen-Cilag International NV | - | Trevicta (paliperidone palmitate) three-month Inj | schizophrenia | EU | A once-monthly injection of paliperidone palmitate (Xeplion) is already marketed in the EU. |
| Bristol-Myers Squibb & Co. | - | Opdivo (nivolumab) | advanced melanoma | EU | For use in combination with Yervoy (ipilimumab) in advanced melanoma. The first combination of two immuno-oncology agents to gain a positive opinion in this condition. |
| Eisai Co. Ltd. | - | Halaven (eribulin) | advanced liposarcoma | EU | A new indication, the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline therapy (unless unsuitable) for advanced or metastatic disease. Halaven is already marketed for breast cancer in the EU. |
| PRIORITY REVIEW | |||||
| Xbiotech Inc. | - | Xilonix (CA-18C, MABp1) | colorectal cancer | EU | An anti-IL-1 antibody granted accelerated review by the CHMP. |
| REGULATORY REVIEW EXTENSION | |||||
| Valeant Pharmaceuticals International Inc. | Progenics Pharmaceuticals Inc. | Relistor (Oral) (methylnaltrexone bromide) | opioid-induced constipation | US | PDUFA date extended by three months to July 19, 2016 so the FDA can review responses to data requests; a sc injection is already approved in the US. |
| PHASE III TRIAL INITIATION | |||||
| Merck KGaA | Pfizer Inc | avelumab | renal cell cancer | Asia, Europe, Latin America, North America | In combination with Inlyta (axitinib) and compared with Sutent (sunitinib malate) monotherapy in the JAVELIN Renal 101 study. |
| AstraZeneca PLC | - | PT-010 | chronic obstructive pulmonary disease (COPD) | - | The Sophos study. |
| PRODUCT LAUNCH | |||||
| Zambon SpA | Newron Pharmaceuticals SpA | Xadago (safinamide) | Parkinson's disease | Belgium | For mid- to late-stage disease; also launched in Switzerland, Germany, Spain and Italy. |
| BTG plc | - | LC Bead LUMI | liver cancer | US | First commercially available radiopaque embolic bead for hypervascular tumors and arteriovenous malformations. |
The table records clinical and regulatory developments using data from BioMedTracker. It lists all drugs for which an event was recorded from April 1 to April 7, 2016, divided by event type.
Events can include latest launches, approvals, withdrawals, suspensions, regulatory filings, CHMP recommendations, Phase III clinical trial initiations, development discontinuations, and the granting of orphan drug and fast-track status.